97. 潰瘍性大腸炎
[臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181

Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
109 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04499495
(ClinicalTrials.gov)
November 30, 202031/7/2020Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in KoreaA Retrospective Study to Assess 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in KoreaUlcerative ColitisOther: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA)Ferring PharmaceuticalsNULLNot yet recruiting15 YearsN/AAll15000NULL
2NCT04133194
(ClinicalTrials.gov)
November 28, 201910/10/2019Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative ColitisAdherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)Ulcerative ColitisDrug: MesalazineCopenhagen University Hospital, HvidovreNULLRecruiting18 Years60 YearsAll200Phase 4Denmark
3EUCTR2019-002070-31-DK
(EUCTR)
05/09/201924/06/2019Compliance to treatment with new single-pill 5-ASA for patients with Ulcerative Colitis (EASI-trial)Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial) Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is unpredictable and characterised by chronic inflammation of the colonic mucosa, where acute attacks are followed by periods of remission. Development of UC is characterized by a dysregulated immune response and barrier dysfunction caused by genetic susceptibility and environmental triggers. UC only involves the colon, starting in the rectum and extending to proximal segments of the colon.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Asacol®
INN or Proposed INN: MESALAZINE
Copenhagen University Hospital HvidovreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 4Denmark
4NCT03804931
(ClinicalTrials.gov)
January 20, 20196/1/2019Fecal Microbiota Transplantation for Ulcerative ColitisEfficacy and Safety of Fecal Microbiota Transplantation for Ulcerative ColitisUlcerative Colitis;Fecal Microbiota TransplantationProcedure: Fecal microbiota transplantation;Procedure: Infusion of Saline;Drug: 5-Aminosalicylic acid(5-ASA) and/or PrednisoneGuangzhou First People's HospitalNULLRecruiting18 Years65 YearsAll120Phase 2;Phase 3China
5NCT03546868
(ClinicalTrials.gov)
August 14, 201810/5/2018Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel DiseasePhase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Subjects With Inflammatory Bowel Disease.Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn DiseaseDrug: [18F]FSPGAsan FoundationNULLCompleted19 Years79 YearsAll20Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-UMIN000026175
2017/06/2301/03/2017Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitisComparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis Ulcerative colitisTime dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa .

PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part .
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu UniversityNULLComplete: follow-up complete20years-old99years-oldMale and Female60Not applicableJapan
7EUCTR2015-002558-11-LV
(EUCTR)
01/09/201601/07/2016A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia
8EUCTR2015-002557-35-LV
(EUCTR)
01/09/201601/07/2016A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis Active, mild to moderate ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia
9NCT02665845
(ClinicalTrials.gov)
June 13, 201625/1/2016Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial.Ulcerative ColitisDrug: 5-ASA;Drug: CorticosteroidsCentre Hospitalier Universitaire de Saint EtienneNULLRecruiting18 YearsN/AAll160Phase 3France;Greece;Israel;Italy;Korea, Republic of;Serbia
10EUCTR2015-002557-35-HU
(EUCTR)
09/02/201616/11/2015A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis Active, mild to moderate ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-002558-11-HU
(EUCTR)
09/02/201616/11/2015A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis - Ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
12EUCTR2015-002557-35-BE
(EUCTR)
07/12/201504/11/2015A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis Active, mild to moderate ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia
13EUCTR2015-002558-11-BE
(EUCTR)
07/12/201504/11/2015A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia;New Zealand;Korea, Republic of
14JPRN-UMIN000019310
2015/11/0101/11/2015Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis ulcerative colitisArm A: Increase of oral 5-ASA (oral administration of 5-ASA in a maximum dose for 8 weeks)
Arm B: Increase of oral 5-ASA and addition of 5-ASA suppository (oral administration of 5-ASA in a maximum dose for 8 weeks and topical administration of 1 g of 5-ASA suppository for 4 weeks)
Department of Gastroenterology and Hepatology, Osaka University Graduate School of MedicineNULLComplete: follow-up complete16years-oldNot applicableMale and Female90Not selectedJapan
15JPRN-UMIN000018075
2015/06/2625/06/2015Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions Ulcerative colitisnormal dosage of 5-ASA (dosage for maintenance therapy) to maximaum dosage of 5-ASA
no optimized therapy
Center for Diagnostic and Therapeutic Endoscopy,Keio UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female100Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-000366-11-RO
(EUCTR)
25/03/201511/03/2015Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Serbia;Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
17EUCTR2013-000366-11-SK
(EUCTR)
19/06/201421/05/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Latvia;Sweden
18EUCTR2013-000366-11-BG
(EUCTR)
23/04/201406/03/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
19EUCTR2013-000366-11-LV
(EUCTR)
14/03/201407/02/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
20EUCTR2013-000366-11-LT
(EUCTR)
10/03/201422/01/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21ChiCTR-TRC-14004153
2014-03-012014-01-03Research on Quality of Life in Patients with Ulcerative Colitis of type of sificiency of spleen and retention of damp-heat receiving Jian Pi Qing Chang [JPQC] decoctionResearch on Quality of Life in Patients with Ulcerative Colitis of type of sificiency of spleen and retention of damp-heat receiving Jian Pi Qing Chang [JPQC] decoction Ulcerative colitisWestern Medicine:5-ASA;TCM:Jian Pi Qing Chang [JPQC] decoction ;Department of Gastroenterology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, ChinaNULLCompleted1875BothWestern Medicine:60;TCM:60;I (Phase 1 study)NULL
22EUCTR2013-000366-11-HU
(EUCTR)
24/02/201428/11/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
23JPRN-JapicCTI-142475
24/12/2013Phase 3 Clinical Trial with MD-0901Phase 3 Clinical Trial with MD-0901 Mild to moderate active ulcerative colitisIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 4.8 g/d are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : Asacol tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 3.6 g/d are administrated orally 3 times daily after each meal for 8 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.NULL16BOTH250Phase 3NULL
24EUCTR2013-000366-11-PL
(EUCTR)
12/12/201305/09/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Latvia;Sweden
25EUCTR2013-000366-11-ES
(EUCTR)
07/10/201312/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26JPRN-UMIN000010127
2013/09/2401/04/2013Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis ulcerative colitisEligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks
Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks
Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks
Department of Gastroenterology and Hepatology, Kyoto University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not applicableJapan
27EUCTR2013-000366-11-CZ
(EUCTR)
12/09/201305/06/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
28EUCTR2013-000366-11-BE
(EUCTR)
02/09/201311/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
29NCT01941589
(ClinicalTrials.gov)
September 201330/8/2013Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative ColitisCombination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.Ulcerative ColitisDrug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids onlySheba Medical CenterNULLRecruiting18 YearsN/AAll160Phase 4China;France;Greece;Israel;Italy;Korea, Republic of;Serbia
30EUCTR2013-000366-11-FI
(EUCTR)
20/08/201305/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2013-000366-11-IE
(EUCTR)
17/07/201316/05/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
32EUCTR2013-000366-11-DK
(EUCTR)
10/07/201310/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
33NCT01903252
(ClinicalTrials.gov)
July 20139/7/2013TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative ColitisAcute Ulcerative ColitisDrug: TP05;Drug: Asacol 400 mgTillotts Pharma AGNULLCompleted18 YearsN/AAll817Phase 3Switzerland;Netherlands
34EUCTR2013-000366-11-SE
(EUCTR)
28/06/201313/05/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
35JPRN-UMIN000010906
2013/06/1010/06/2013The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission. Ulcerative ColitisA 24-week administration of 4.8g/day of Asacol
A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy
Chiba University HospitalNULLComplete: follow-up complete15years-old70years-oldMale and Female60Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04032652
(ClinicalTrials.gov)
December 20124/12/2012Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving AsacolMeasurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on AsacolUlcerative ColitisProcedure: Rectal dialysis;Drug: Rectal dialysisNorthShore University HealthSystemNULLTerminated18 Years45 YearsAll2Phase 2NULL
37EUCTR2011-005115-82-LT
(EUCTR)
12/09/201224/05/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
38EUCTR2011-005115-82-LV
(EUCTR)
15/06/201221/05/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
39EUCTR2011-005115-82-EE
(EUCTR)
05/06/201209/05/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
40EUCTR2011-005115-82-BG
(EUCTR)
11/05/201211/04/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2011-005115-82-CZ
(EUCTR)
18/04/201208/02/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
42EUCTR2011-005115-82-PL
(EUCTR)
10/04/201216/03/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
43EUCTR2011-005115-82-HU
(EUCTR)
26/03/201207/02/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
44NCT01532648
(ClinicalTrials.gov)
January 27, 201213/12/2011Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA RegimenUlcerative ColitisDrug: Budesonide MMX®;Drug: Placebo;Drug: 5-ASABausch Health Americas, Inc.NULLCompleted18 Years75 YearsAll510Phase 3United States;Bulgaria;Canada;Czechia;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine;Czech Republic
45NCT01346826
(ClinicalTrials.gov)
May 20112/5/2011Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled TrialCrohn's Disease;Ulcerative ColitisDrug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusionAsan Medical CenterNULLCompleted16 Years80 YearsBoth145Phase 4Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT01341808
(ClinicalTrials.gov)
April 201125/4/2011Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) PatientsImmunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;Hepatitis ABiological: Epaxal Berna (virosomal hepatitis A vaccine)Asan Medical CenterNULLCompleted18 Years40 YearsBoth493Phase 4Korea, Republic of
47NCT01257386
(ClinicalTrials.gov)
November 20108/12/2010Comparative Efficacy and Safety Study in Patients With Active Ulcerative ColitisComparative Efficacy and Safety Study in Patients With Active Ulcerative ColitisActive Ulcerative ColitisDrug: Asacol®;Drug: MesalazineTillotts Pharma AGZeria PharmaceuticalCompleted18 Years64 YearsBoth251Phase 3China
48NCT01257399
(ClinicalTrials.gov)
November 20108/12/2010Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission PhaseComparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission PhaseUlcerative Colitis in RemissionDrug: Asacol®;Drug: MesalazineTillotts Pharma AGZeria PharmaceuticalCompleted18 Years64 YearsBoth251Phase 3China
49JPRN-UMIN000003785
2010/07/0101/07/2010Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. Ulcerative colitis5-aminosalicylic acid monotherapy arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks).

5-aminosalicylic acid monotherapy and tacrolimus arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule.
Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of MedicineNULLComplete: follow-up complete16years-old65years-oldMale and Female80Phase 3Japan
50NCT01059344
(ClinicalTrials.gov)
November 200928/1/2010Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative ColitisA Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative ColitisUlcerative ColitisDrug: MesalaminTillotts Pharma AGNULLCompleted18 YearsN/AAll281Phase 3Belarus;India;Turkey;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2009-011608-51-DE
(EUCTR)
09/10/200921/07/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Germany;Sweden
52NCT01004185
(ClinicalTrials.gov)
October 200927/10/2009Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative ColitisA Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative ColitisUlcerative ColitisDrug: Asacol 400 mgWarner ChilcottNULLTerminated5 Years17 YearsAll39Phase 3United States;Canada;Croatia;Poland;Romania;Russian Federation
53EUCTR2004-004184-29-DK
(EUCTR)
10/09/200910/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
54EUCTR2009-010921-38-NL
(EUCTR)
08/09/200902/03/2009Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UCChemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC Ulcerative Colitis and the risk of developing colorectal cancer.
MedDRA version: 13.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Salofalk
INN or Proposed INN: mesalazine
Trade Name: Ursofalk
INN or Proposed INN: ursodeoxycholic acid
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
55EUCTR2009-010065-23-DE
(EUCTR)
17/08/200914/04/2009Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIXConventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX Active Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: 100
Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
INN or Proposed INN: 5-Aminosalicylic acid
Trade Name: Imurek 25mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Imurek 50mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Decortin H 1 mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 5mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 10mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 20mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 50 mg
INN or Proposed INN: prednisolone
Essex Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2009-011608-51-SE
(EUCTR)
17/08/200922/06/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
60Germany;Sweden
57EUCTR2009-011608-51-BE
(EUCTR)
03/08/200923/06/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Belgium;Germany;Sweden
58EUCTR2008-007292-25-IT
(EUCTR)
24/03/200916/03/2009AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure)
MedDRA version: 9.1;Level: LLT;Classification code 10024123;Term: Left-sided ulcerative (chronic) colitis
Trade Name: MEZAVANT
INN or Proposed INN: Mesalazine
Trade Name: ASACOL
INN or Proposed INN: Mesalazine
GIULIANINULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
59NCT00713310
(ClinicalTrials.gov)
December 20089/7/2008Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative ColitisStudy to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative ColitisUlcerative ColitisDrug: Asacol 400 mgWarner ChilcottNULLCompleted5 Years17 YearsAll83Phase 3United States;Canada;Croatia;Poland;Romania
60ChiCTR-TRC-08000145
2008-09-012008-08-25The study of the treatment and rehabilitation of ulcerative colitisThe study of the treatment and rehabilitation of ulcerative colitis Ulcerative Colitis1:5-ASA and low residue diet;2:5-ASA and EN;3:5-ASA and low residue diet and microecology prepar;4:5-ASA and low residue diet ang Gln;5:5-ASA and EN and Gln and microecology preparation;Friendship Hospital of Capital Medical UniversityNULLCompleted1870Both1:60;2:60;3:60;4:60;5:60;I (Phase 1 study)China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT00679432
(ClinicalTrials.gov)
June 200814/5/2008(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative ColitisEfficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.Ulcerative ColitisProcedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mgBausch Health Americas, Inc.NULLCompleted18 Years75 YearsAll510Phase 3United States;Canada;India;Mexico
62EUCTR2007-004732-23-PL
(EUCTR)
05/05/200812/05/2008A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.)A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.) Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
Product Name: Mesalamine
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE
EMET Pharmaceuticals, LLCNULLNot RecruitingFemale: yes
Male: yes
435Estonia;Latvia;Poland
63EUCTR2007-004732-23-LV
(EUCTR)
27/02/200828/02/2008A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative ColitisA Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE
EMET Pharmaceuticals LLCNULLNot RecruitingFemale: yes
Male: yes
435Estonia;Latvia;Poland
64EUCTR2004-004184-29-NL
(EUCTR)
15/01/200817/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
65NCT01045018
(ClinicalTrials.gov)
January 200817/12/2009A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative ColitisBE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative ColitisMild to Moderate Ulcerative ColitisDrug: Placebo;Drug: MesalamineEMET Pharmaceuticals, LLCEagle Pharmaceuticals, Inc.Completed18 YearsN/ABothPhase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2004-004184-29-PT
(EUCTR)
14/12/200711/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
67EUCTR2004-004184-29-SE
(EUCTR)
22/11/200727/09/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
68EUCTR2007-004732-23-EE
(EUCTR)
22/10/200723/10/2007A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative ColitisA Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE
EMET Pharmaceuticals LLCNULLNot RecruitingFemale: yes
Male: yes
435Estonia;Latvia;Poland
69NCT00603733
(ClinicalTrials.gov)
October 200716/1/2008Canadian Active & Maintenance Modified Pentasa StudyA Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 WeeksActive Ulcerative Colitis;Remission of Ulcerative ColitisDrug: 5-ASA (5-Aminosalicylate)Ferring PharmaceuticalsNULLCompleted18 Years75 YearsAll288Phase 3Canada
70NCT00505778
(ClinicalTrials.gov)
July 200720/7/2007A Comparison of Once a Day Dose Compared to 2 Doses/DayA Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative ColitisUlcerative ColitisDrug: Mesalamine Once-Daily;Drug: Mesalamine Twice-DailyWarner ChilcottNULLCompleted18 YearsN/AAll1027Phase 3United States;Canada;Puerto Rico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2006-001782-42-HU
(EUCTR)
20/12/200616/08/2006Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. Active left-sided, mild to moderate ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: CB-01-05-MMX
Product Code: CB-01-05-MMX
Other descriptive name: PARNAPARIN SODIUM
Cosmo Technologies LtdNULLNot RecruitingFemale: yes
Male: yes
120Hungary;United Kingdom;Italy
72EUCTR2006-001782-42-IT
(EUCTR)
03/11/200620/12/2006Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - NDEfficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND Patients with mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: CB-01-05-MMX COSMO TECHNOLOGIES LTDNULLNot RecruitingFemale: yes
Male: yes
120Hungary;United Kingdom;Italy
73EUCTR2006-001782-42-GB
(EUCTR)
17/10/200629/09/2006Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. Active left-sided, mild to moderate ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Cosmo Technologies LtdNULLNot Recruiting Female: yes
Male: yes
120Phase 2Hungary;Italy;United Kingdom
74NCT00708656
(ClinicalTrials.gov)
October 20068/4/2008The Colitis Once Daily Asacol StudyA Randomized, Single-Blind Study to Assess Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily Versus Divided Doses 3 Times Daily for 12 Months in Maintenance of Remission of Ulcerative Colitis.Ulcerative ColitisDrug: mesalazine (Asacol®)Cardiff and Vale University Health BoardProcter and GambleCompleted18 YearsN/AAll213Phase 3United Kingdom
75NCT00343850
(ClinicalTrials.gov)
September 200621/6/2006Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative ColitisOnce Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis: A Randomized Pilot TrialUlcerative ColitisDrug: Asacol (mesalamine)University of ChicagoProcter and GambleCompleted18 YearsN/ABoth30Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2006-001310-32-LT
(EUCTR)
17/07/200615/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
77NCT00349388
(ClinicalTrials.gov)
July 20065/7/2006Safety and Compliance of Taking Mesalamine Once a Day in Pediatric PatientsA Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative ColitisUlcerative ColitisDrug: AsacolAnnette LangsederProcter and GambleTerminated6 Years18 YearsAll1N/AUnited States
78EUCTR2006-001310-32-HU
(EUCTR)
29/06/200623/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
79EUCTR2006-001310-32-CZ
(EUCTR)
26/06/200617/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
80EUCTR2006-001310-32-EE
(EUCTR)
16/06/200627/04/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00350415
(ClinicalTrials.gov)
June 20066/7/2006A Double Blind Study for the Treatment of Acute Ulcerative ColitisA Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.Ulcerative ColitisDrug: MesalamineWarner ChilcottNULLCompleted18 Years75 YearsBoth772Phase 3United States;Belarus;Canada;Croatia;Czech Republic;Estonia;Hungary;Latvia;Lithuania;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro
82NCT00408174
(ClinicalTrials.gov)
May 20064/12/2006Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative ColitisInflammatory Bowel Disease;Ulcerative ColitisDrug: Balsalazide disodiumBausch Health Americas, Inc.NULLCompleted18 YearsN/AAll400Phase 3United States
83EUCTR2006-001310-32-LV
(EUCTR)
28/04/200622/08/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III Ulcerative ColitisProduct Name: Asacol 800mg tablet
INN or Proposed INN: mesalazine
Product Name: Asacol 400mg tablet
INN or Proposed INN: mesalazine
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
470Hungary;Czech Republic;Estonia;Latvia;Lithuania
84EUCTR2005-002784-91-GB
(EUCTR)
06/02/200624/11/2005A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol)A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol) Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Cardiff and Vale NHS TrustNULLNot Recruiting Female: yes
Male: yes
630Phase 3United Kingdom
85NCT00269438
(ClinicalTrials.gov)
December 200522/12/2005New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative ColitisPhase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of TherapyUlcerative ColitisDrug: 5 ASA, enemas, suppositories, corticosteroidsBausch Health Americas, Inc.NULLCompleted18 Years80 YearsAll225Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT00254618
(ClinicalTrials.gov)
October 200514/11/2005A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.Study to Determine the Pharmacokinetics of Mesalamine Following Administration of 30, 60, and 90 mg/kg/Day as 400 mg Delayed-release Tablets Given Every 12 Hours for 28 Days to Children/Adolescents With Active Ulcerative Colitis.Ulcerative ColitisDrug: mesalamineWarner ChilcottNULLTerminated5 Years17 YearsBoth34Phase 1United States
87EUCTR2004-000734-36-CZ
(EUCTR)
13/07/200508/10/2004A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this studyProduct Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)
Shire Pharmaceutical Development Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
125Phase 3Czech Republic
88EUCTR2004-004184-29-DE
(EUCTR)
06/06/200501/03/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitisProduct Name: None given
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
410Phase 3Portugal;Hungary;Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Spain;Sweden
89EUCTR2004-001677-26-IT
(EUCTR)
06/06/200515/02/2006Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week studyNolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study Patients with 5-aminosalicylic 5-ASA or sulphasalazine resistant ulcerative colitis
MedDRA version: 6.1;Level: PT;Classification code 10009900
Product Name: Nolpitantium Besylate
Product Code: SR140333B
SANOFI-SYNTHELABONULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
90EUCTR2004-004184-29-GB
(EUCTR)
31/05/200523/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Shire Pharmaceutical Development LtdNULLNot Recruiting Female: yes
Male: yes
826Phase 3Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2004-004184-29-ES
(EUCTR)
05/05/200503/04/2006A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis.A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. Ulcerative colitis
MedDRA version: 3.2;Level: LLT;Classification code 10045365
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
410Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
92EUCTR2004-004184-29-CZ
(EUCTR)
13/04/200511/04/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden
93NCT00151892
(ClinicalTrials.gov)
April 20057/9/2005Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative ColitisA Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative ColitisUlcerative ColitisDrug: SPD476;Drug: AsacolShireNULLCompleted18 YearsN/AAll829Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;Czech Republic;Denmark;France;Germany;Hungary;India;Korea, Republic of;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom
94EUCTR2004-004184-29-HU
(EUCTR)
30/03/200510/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
95EUCTR2004-001677-26-EE
(EUCTR)
23/03/200523/03/2005Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
Sanofi-Synthelabo RechercheNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2004-001677-26-SE
(EUCTR)
07/02/200523/12/2004Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
Sanofi-Synthelabo RechercheNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
97EUCTR2004-001677-26-HU
(EUCTR)
25/01/200503/11/2004Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
Sanofi-Synthelabo RechercheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
98EUCTR2004-001677-26-ES
(EUCTR)
14/01/200501/06/2005Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
Sanofi-Synthelabo RechercheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
99EUCTR2004-000611-25-IE
(EUCTR)
19/10/200416/08/2004A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - COREA Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE Maintenance of remission of ulcerative colitisProduct Name: OPC-6535
Product Code: OPC-6535
Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid
Trade Name: Asacol (mesalamine) Delayed-release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalamine
Other descriptive name: 5-amino-2-hydroxybenzoic acid
Otsuka Maryland Research Institute, Inc.NULLNot RecruitingFemale: yes
Male: yes
1725Phase 3Hungary;Ireland
100EUCTR2004-000611-25-HU
(EUCTR)
15/10/200421/07/2004A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - COREA Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE Maintenance of remission of ulcerative colitisProduct Name: OPC-6535
Product Code: OPC-6535
Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid
Trade Name: Asacol (mesalamine) Delayed-release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalamine
Other descriptive name: 5-amino-2-hydroxybenzoic acid
Otsuka Maryland Research Institute, Inc.NULLNot RecruitingFemale: yes
Male: yes
1725Phase 3Hungary;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2004-000916-25-IT
(EUCTR)
28/09/200418/05/2005A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITISA PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS TREATMENT OF ULCERATIVE COLITIS IN ACTIVE PHASE AND IN THE MAINTENANCE OF CLINICAL REMISSION
MedDRA version: 6.1;Level: PT;Classification code 10021972
Product Name: 5-ASA MMx
INN or Proposed INN: Mesalazine
GIULIANINULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
102EUCTR2004-000733-12-CZ
(EUCTR)
14/07/200401/07/2004A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.Product Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)
Shire Pharmaceutical Development IncNULLNot RecruitingFemale: yes
Male: yes
255Phase 3Czech Republic
103NCT00092508
(ClinicalTrials.gov)
May 200422/9/2004CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) RemissionPhase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis RemissionUlcerative ColitisDrug: OPC-6535;Drug: Asacol®Otsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years80 YearsBoth1725Phase 3United States
104EUCTR2004-001677-26-CZ
(EUCTR)
09/03/200410/02/2005Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
sanofi-aventis recherche & developpementNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
105NCT00548574
(ClinicalTrials.gov)
December 200323/10/2007Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative ColitisA Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine;Drug: MesalazineShireNULLCompleted18 YearsN/ABoth343Phase 3Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT00194818
(ClinicalTrials.gov)
June 200315/9/2005Asacol Dosing Study for Active Ulcerative ColitisOpen Label Safety and Efficacy Trial of Twice Daily Dosing of Asacol vs. Three Times Per Day Dosing for the Induction of Remission in Active Ulcerative ColitisUlcerative ColitisDrug: Asacol (mesalamine)University of WashingtonProcter and GambleCompleted18 Years80 YearsBoth7Phase 4United States
107NCT00577473
(ClinicalTrials.gov)
February 200119/12/2007Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/DayUlcerative ColitisDrug: mesalamineWarner ChilcottNULLCompleted18 Years65 YearsAll301Phase 3United States
108NCT00073021
(ClinicalTrials.gov)
September 200013/11/2003Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative ColitisA Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative ColitisUlcerative ColitisDrug: Asacol 800 mg (mesalamine);Drug: Asacol 400 mg (mesalamine)Warner ChilcottNULLCompleted18 Years75 YearsAll386Phase 3United States;Canada;Puerto Rico
109EUCTR2007-005702-49-PL
(EUCTR)
17/06/2009A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP IIA Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents
MedDRA version: 11.0;Level: LLT;Classification code 10045365;Term:
Trade Name: Asacol
Product Name: Asacol
Product Code: NA
INN or Proposed INN: MESALAZINE
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Poland