Mesalamine ( DrugBank: Mesalamine )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病9
97潰瘍性大腸炎99
98好酸球性消化管疾患1
164眼皮膚白皮症1

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01696942
(ClinicalTrials.gov)
February 201325/9/2012Cimzia Versus Mesalamine for Crohn's RecurrenceUse of Certolizumab Following Ileocolectomy Lowers Endoscopic and Histological Recurrence Rates for Crohn's Disease at One Year Compared to MesalamineCrohn's DiseaseDrug: Cimzia;Drug: MesalamineMilton S. Hershey Medical CenterUCB PharmaTerminated18 YearsN/AAll10Phase 4United States
2NCT00862121
(ClinicalTrials.gov)
April 200913/3/2009A Study With Pentasa in Patients With Active Crohn's DiseasePENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.Crohn´s DiseaseDrug: Pentasa;Drug: PlaceboFerring PharmaceuticalsNULLTerminated18 YearsN/AAll20Phase 3United States;Belgium;Denmark;France;Germany;Sweden;United Kingdom;Spain
3NCT00245505
(ClinicalTrials.gov)
February 200926/10/2005The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active Drug: Crohn's DiseaseThe Effect on Mucosal Healing With Pentasa Sachet 4g in Mild to Moderate Active Small Bowel Crohn´s Disease, Evaluated by Video Capsule Endoscopy After 6 and 12 Weeks Treatment. A Pilot StudyCrohn's DiseaseDrug: Mesalazine (Mesalamine)Ferring PharmaceuticalsNULLTerminated18 Years70 YearsBoth3Phase 3Sweden
4EUCTR2008-002100-26-BE
(EUCTR)
28/01/200931/07/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510France;Belgium;Denmark;Germany;United Kingdom;Sweden
5EUCTR2008-002100-26-FR
(EUCTR)
16/01/200902/09/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placeboPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Phase 3France;Belgium;Denmark;Germany;United Kingdom;Sweden
6EUCTR2008-002100-26-GB
(EUCTR)
07/01/200919/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
7EUCTR2008-002100-26-SE
(EUCTR)
27/11/200808/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
8EUCTR2008-002100-26-DE
(EUCTR)
19/11/200806/03/2009PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510France;Belgium;Denmark;Germany;United Kingdom;Sweden
9EUCTR2008-002100-26-DK
(EUCTR)
04/11/200818/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Belgium;Denmark;France;Sweden

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05753267
(ClinicalTrials.gov)
February 28, 202322/2/2023Fenofibrate in Ulcerative ColitisClinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative ColitisInflammatory Bowel DiseasesDrug: Mesalamine;Drug: Fenofibrate 160mgTanta UniversityEman Ibrahim Elberri, Faculty of Pharmacy, Tanta University;Hend El-Said Abo Mansour, Faculty of Pharmacy, Menoufia University;Monir Hussein Bahgat, Faculty of Medicine, Mansura University;Eman Maamoun Ali El-Khateeb, Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Tanta UniversityRecruiting18 Years75 YearsAll60Phase 2/Phase 3Egypt
2NCT05567068
(ClinicalTrials.gov)
February 1, 20231/10/2022Atorvastatin Efficacy and Safety in Patients With Ulcerative ColitisRepurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.Inflammatory Bowel DiseasesDrug: Atorvastatin 80mg;Drug: MesalamineTanta UniversityNULLNot yet recruiting18 Years75 YearsAll44Phase 2NULL
3NCT05574387
(ClinicalTrials.gov)
January 20, 20236/10/2022Metformin as Added on Therapy in Patients With Ulcerative ColitisMetformin, The Biguanide Derivative, as Adjuvant Therapy in Patients With Ulcerative Colitis Treated With MesalamineInflammatory Bowel DiseasesDrug: MetforminTanta UniversityPrincipal Investigator Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University;Principal Investigator Sahar Hegazy, Prof Clinical pharmacy Department- Tanta University;Principal Investigator Mostafa Mahmoud Bahaa El-Dien Pharmacy Practice Department- Horus UniversityRecruiting18 Years75 YearsAll46Phase 2Egypt
4NCT05316220
(ClinicalTrials.gov)
December 31, 202231/3/2022A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative ColitisA Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative ColitisUlcerative Colitis (UC)Drug: Mesalamine;Drug: PlaceboAbbVieNULLNot yet recruiting5 Years17 YearsAll80Phase 3United States;Puerto Rico
5NCT05553704
(ClinicalTrials.gov)
November 1, 202220/9/2022Metformin in Patients With Ulcerative Colitis Treated With MesalamineClinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With MesalamineInflammatory Bowel DiseasesDrug: MetforminTanta UniversityNULLRecruiting18 Years75 YearsAll52Phase 2Egypt
6NCT05626166
(ClinicalTrials.gov)
November 20229/11/2022the Efficacy and Safety of Diosmin in Patients With Ulcerative ColitisClinical Study Evaluating the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis Treated With MesalamineUlcerative ColitisDrug: Placebo;Drug: DiosminTanta UniversityNULLNot yet recruiting18 YearsN/AAll60Phase 3NULL
7NCT05558761
(ClinicalTrials.gov)
October 10, 202225/9/2022Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative ColitisClinical Study to Evaluate the Possible Efficacy of Pentoxifylline in Patients With Ulcerative Colitis Treated With MesalamineInflammatory Bowel DiseasesDrug: Pentoxifylline 400 MGTanta UniversityNULLRecruiting18 Years75 YearsAll50Phase 2Egypt
8NCT05119140
(ClinicalTrials.gov)
June 10, 202220/10/2021HCQ for Non Europeans With Mild to Severe UCAdministration of Hydroxychloroquine (Plaquenil) to Individuals of Non-European Ancestry for the Treatment of Mild to Severe Ulcerative Colitis.Ulcerative Colitis (Disorder)Drug: Hydroxychloroquine;Drug: MesalamineIcahn School of Medicine at Mount SinaiCrohn's and Colitis FoundationRecruiting18 YearsN/AAll20Phase 1/Phase 2United States
9ChiCTR2000037261
2020-10-012020-08-27Study on the clinic of stasis removing and renewal therapy for ulcerative colitis based on serum exosome miRNA to regulate the immune microenvironmentStudy on the clinic of stasis removing and renewal therapy for ulcerative colitis based on serum exosome miRNA to regulate the immune microenvironment Ulcerative Colitisexperimental group:stasis removing and immunoregulation therapy;control group:mesalamine;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, ShanghaiNULLRecruiting1865Bothexperimental group:30;control group:30;China
10NCT03923478
(ClinicalTrials.gov)
June 24, 201915/4/2019ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine TreatmentUlcerative Colitis Chronic Mild;Ulcerative Colitis Chronic ModerateDrug: ABI-M201;Drug: PlaceboAssembly BiosciencesNULLTerminated18 Years70 YearsAll15Phase 1United States;Canada
11ChiCTR1900021229
2019-02-182019-02-02The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitisThe role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitis Ulcerative colitisIntervention group:Increasing the dose of mesalamine according to fecal calprotectin levels;Control group:Maintaining current dosage of mesalamine;Beijing Friendship Hospital, Capital Medical UniversityNULLPendingBothIntervention group:74;Control group:74;China
12NCT03716388
(ClinicalTrials.gov)
December 1, 201821/10/2018Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UCFecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot StudyUlcerative Colitis Chronic Mild;Ulcerative Colitis Chronic ModerateBiological: Fecal Microbiota Transplantation;Drug: Mesalamine Granules;Other: Placebo infusion;Other: Placebo granulesDayanand Medical College and HospitalColitis & Crohn's Foundation (India)Recruiting18 Years75 YearsAll20Phase 3India
13EUCTR2013-001744-65-BE
(EUCTR)
23/01/201827/02/2017A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant Gastro-resistant, prolonged release tablets
Product Name: Mezavant
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
14EUCTR2013-001744-65-DE
(EUCTR)
10/01/201820/02/2017A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant Gastro-resistant, prolonged release tablets
Product Name: Mezavant
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
15ChiCTR2100043797
2018-01-012021-02-28The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitisThe efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis Ulcerative colitisCase series:Single or multiple FMT were performed via the working channel of the colonoscope or transendoscopic enteral tubing in 2 months. All patients were given concomitant oral mesalamine (4g/d) and patients who were taking corticosteroid did a mandatory taper of 2.5 mg per week until it was withdrawn.;Department of Gastroenterology, Jinan Central HospitalNULLCompleted2181BothCase series:28;N/AChina
16NCT03415711
(ClinicalTrials.gov)
April 28, 20175/1/2018PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative ColitisA Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UCUlcerative ColitisDietary Supplement: VSL#3®;Drug: Mesalamine;Drug: PlaceboVSL PharmaceuticalsActial Farmaceutica S.r.l.Terminated18 Years85 YearsAll14N/AItaly
17EUCTR2015-002558-11-BG
(EUCTR)
14/03/201706/01/2017A 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: 20.0;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 Recruiting Female: yes
Male: yes
260 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
18EUCTR2015-002557-35-BG
(EUCTR)
14/03/201706/01/2017A 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: 20.0;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 Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
19NCT02910245
(ClinicalTrials.gov)
November 20169/9/2016Mercaptopurine Therapy in Ulcerative ColitisEfficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC)Colitis, UlcerativeDrug: Mercaptopurine (Purinethol);Drug: Placebo;Drug: Mesalamine;Drug: PrednisoneAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)ZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruiting18 Years80 YearsAll136Phase 3Netherlands
20EUCTR2015-002557-35-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
21EUCTR2015-002558-11-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
22NCT02849951
(ClinicalTrials.gov)
July 201626/7/2016A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With MesalamineUlcerative ColitisDrug: LT-02;Drug: LT-02 PlaceboPrometheus LaboratoriesNestlé Health Science Spain;INC ResearchTerminated18 Years70 YearsAll25Phase 3United States
23EUCTR2013-001205-84-BE
(EUCTR)
11/03/201617/02/2015LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
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 Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
24EUCTR2013-001205-84-HU
(EUCTR)
07/03/201604/01/2016LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
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 Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
25EUCTR2015-002557-35-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
26EUCTR2015-002558-11-HU
(EUCTR)
09/02/201616/11/2015A 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 A 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.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3United States;Serbia;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
27NCT02522780
(ClinicalTrials.gov)
February 1, 201612/8/2015Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)A 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 ColitisUlcerative ColitisDrug: Mesalamine;Drug: PlaceboFerring PharmaceuticalsNULLCompleted18 Years75 YearsAll276Phase 3United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium
28EUCTR2015-002557-35-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
29EUCTR2015-002558-11-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
30EUCTR2015-001022-42-IT
(EUCTR)
01/12/201529/03/2019A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative ColitisA Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis Active, Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: IBD98-M Delayed-release Capsules
Product Code: IBD98-M
INN or Proposed INN: SODIUM HYALURONATE
Other descriptive name: SODIUM HYALURONATE
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-ASA
Holy Stone Healthcare Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
51 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly
31EUCTR2013-001205-84-AT
(EUCTR)
13/10/201502/09/2015LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
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 Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
32NCT02522767
(ClinicalTrials.gov)
October 201512/8/2015Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)A 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 ColitisUlcerative ColitisDrug: Mesalamine;Drug: PlaceboFerring PharmaceuticalsNULLCompleted18 Years75 YearsAll228Phase 3United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium
33EUCTR2013-001205-84-SK
(EUCTR)
23/03/201505/02/2015LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
34EUCTR2013-001744-65-NL
(EUCTR)
02/03/201507/08/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate 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]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Devlopment LLCNULLNot Recruiting Female: yes
Male: yes
128 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Germany;Netherlands;United Kingdom
35EUCTR2013-001205-84-LV
(EUCTR)
26/02/201523/12/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
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 Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Germany;Netherlands
36EUCTR2013-001205-84-PL
(EUCTR)
20/01/201522/09/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
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 Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands
37EUCTR2013-001205-84-DE
(EUCTR)
13/01/201508/08/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
38NCT02093663
(ClinicalTrials.gov)
December 12, 201417/3/2014Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance PhasesUlcerative ColitisDrug: MMX Mesalamine/Mesalazine (Low Dose);Drug: MMX Mesalamine/Mesalazine (High Dose)ShireNULLCompleted5 Years17 YearsAll107Phase 3United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands
39EUCTR2013-001744-65-GB
(EUCTR)
22/10/201431/03/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Development LLCNULLNot Recruiting Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
40EUCTR2012-003702-27-BE
(EUCTR)
21/10/201404/02/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia
41EUCTR2013-001744-65-PL
(EUCTR)
20/10/201419/08/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant Gastro-resistant, prolonged release tablets
Product Name: Mezavant
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Devlopment LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Netherlands;Germany;United Kingdom;Sweden
42NCT02280629
(ClinicalTrials.gov)
October 1, 201429/10/2014Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative ColitisUlcerative ColitisDrug: LT-02;Drug: Placebo;Drug: MesalamineDr. Falk Pharma GmbHNULLCompleted18 Years70 YearsAll150Phase 3Germany
43EUCTR2012-003702-27-NL
(EUCTR)
30/09/201414/04/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia
44EUCTR2013-001744-65-HU
(EUCTR)
24/09/201415/07/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Devlopment LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom
45EUCTR2013-001744-65-SK
(EUCTR)
11/09/201417/07/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant Gastro-resistant, prolonged release tablets
Product Name: Mezavant
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Devlopment LLCNULLNot Recruiting Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
46EUCTR2012-003702-27-PL
(EUCTR)
29/07/201420/05/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
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 Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands
47NCT02142725
(ClinicalTrials.gov)
July 21, 201415/5/2014Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative ColitisRandomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With MesalamineUlcerative ColitisDrug: LT-02;Drug: PlaceboDr. Falk Pharma GmbHNULLTerminated18 Years70 YearsAll468Phase 3Germany
48EUCTR2012-003702-27-SK
(EUCTR)
10/06/201406/03/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
49EUCTR2012-003702-27-LV
(EUCTR)
20/05/201425/03/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Netherlands;Germany
50EUCTR2012-003702-27-HU
(EUCTR)
19/05/201407/03/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
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 Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Hungary;Czech Republic;Belgium;Poland;Germany;Latvia;Netherlands
51EUCTR2012-003702-27-CZ
(EUCTR)
15/05/201424/02/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
52EUCTR2012-003702-27-LT
(EUCTR)
12/05/201419/03/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia
53EUCTR2012-003702-27-DE
(EUCTR)
08/05/201430/12/2013LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
54EUCTR2012-003702-27-AT
(EUCTR)
02/04/201410/02/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia
55EUCTR2011-000164-10-GB
(EUCTR)
04/01/201319/09/2012Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative ColitisA Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis 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 Code: SPD476
INN or Proposed INN: mesalazine
Product Code: SPD476
INN or Proposed INN: mesalazine
Trade Name: Mezavant XL 1200mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
64Phase 1United States;Slovakia;Poland;Australia;United Kingdom
56NCT01536535
(ClinicalTrials.gov)
July 10, 201216/2/2012Predicting Response to Standardized Pediatric Colitis TherapyMulticenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis.Ulcerative ColitisDrug: Mesalazine;Drug: IV Corticosteroid;Drug: Oral Corticosteroids;Other: Additional Therapies;Procedure: ColectomyConnecticut Children's Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed4 Years17 YearsAll431Phase 4United States;Canada
57EUCTR2011-000164-10-SK
(EUCTR)
21/06/201213/04/2016Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative ColitisA Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis 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 Name: SPD476
Product Code: SPD476
INN or Proposed INN: mesalazine
Product Name: SPD476
Product Code: SPD476
INN or Proposed INN: mesalazine
Product Name: SPD476
Product Code: SPD476
INN or Proposed INN: mesalazine
Shire Development IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 1United States;Slovakia;United Kingdom
58NCT01586533
(ClinicalTrials.gov)
June 201225/4/2012Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative ColitisA Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative ColitisUlcerative Colitis;Left-sided Ulcerative Colitis;Distal Ulcerative ColitisDrug: Zoenasa-1:4;Drug: Mesalamine EnemaAltheus Therapeutics, Inc.NULLActive, not recruiting18 Years64 YearsBoth120Phase 2United States
59EUCTR2009-017044-13-DE
(EUCTR)
03/11/201016/06/2010A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM Ulcerative Colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development IncNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
60NCT01130844
(ClinicalTrials.gov)
October 8, 201020/5/2010Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative ColitisA Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative ColitisUlcerative ColitisDrug: MMX MesalamineShireNULLCompleted5 Years17 YearsAll52Phase 1United States;Australia;Poland;Slovakia;United Kingdom
61EUCTR2009-017044-13-BE
(EUCTR)
14/09/201006/05/2010A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany
62NCT01201122
(ClinicalTrials.gov)
September 201012/9/2010Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative ColitisMulti Center Ulcerative Colitis Pediatric Pentasa Intervention Trial (MUPPIT). A Randomized, Single-blinded, Controlled, Parallel, Induction Therapy With Once vs. Twice Daily Dosing of Pentasa in Pediatric UC.Mild to Moderate Ulcerative ColitisDrug: MesalamineWolfson Medical CenterNULLCompleted6 Years18 YearsBoth86Phase 4Israel
63EUCTR2009-017044-13-IE
(EUCTR)
10/08/201020/04/2010A study to Evaluate the Ability to Maintain Clinical andEndoscopic Remission During a 12-Month period with 2.4g/day of druggiven once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM 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]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
64EUCTR2009-017044-13-CZ
(EUCTR)
05/08/201028/05/2010A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM 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]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Hungary;Canada;Poland;South Africa;Germany;United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Czech Republic
65EUCTR2009-017044-13-FR
(EUCTR)
27/07/201022/06/2010A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative ColitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development IncNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom
66EUCTR2009-017044-13-HU
(EUCTR)
21/07/201026/04/2010A Study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM 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]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
67EUCTR2009-017044-13-GB
(EUCTR)
30/06/201017/03/2010A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM 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]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development LLCNULLNot Recruiting Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;South Africa;Germany
68NCT01124149
(ClinicalTrials.gov)
June 29, 201013/5/2010Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative ColitisA Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative ColitisUlcerative ColitisDrug: MMX mesalamine/ mesalazineShireNULLCompleted18 YearsN/AAll759Phase 4United States;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;India;Ireland;Poland;Romania;South Africa;Spain;United Kingdom;Brazil;Czech Republic
69EUCTR2009-017044-13-ES
(EUCTR)
25/06/201019/04/2010Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative ColitisEstudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis Colitis UlcerosaUlcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development Inc.NULLNot RecruitingFemale: yes
Male: yes
1000Phase 4France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom
70NCT01020708
(ClinicalTrials.gov)
November 200920/11/2009Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative ColitisA Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative ColitisUlcerative ColitisDrug: mesalamine;Drug: ALTH12-1:4;Drug: ALTH12-2:4Altheus Therapeutics, Inc.NULLCompleted18 Years64 YearsBoth9Phase 1United States
71NCT00652145
(ClinicalTrials.gov)
September 20081/4/2008Dose Escalation and Remission (DEAR)Test Treat Strategy to Prevent Ulcerative Colitis RelapseUlcerative ColitisDrug: mesalamineJames LewisNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);ShireCompleted18 YearsN/AAll119Phase 4United States
72EUCTR2007-005166-12-DE
(EUCTR)
29/07/200815/01/2008A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without MesalamineA Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Product Name: HMPL-004
Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract)
Product Name: HMPL-004
Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract)
Hutchison MediPharma Enterprises LimitedNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Germany
73EUCTR2007-004732-23-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
74EUCTR2007-004732-23-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
75NCT00659802
(ClinicalTrials.gov)
February 7, 20088/4/2008Phase II Study of HMPL-004 in Patients With Ulcerative ColitisA Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without MesalamineUlcerative ColitisDrug: HMPL-004 low dose;Drug: Placebo;Drug: HMPL-004 high doseHutchison Medipharma LimitedNULLCompleted18 YearsN/AAll224Phase 2United States
76NCT01045018
(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
77EUCTR2007-004732-23-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
78NCT00603733
(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
79NCT00505778
(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
80NCT00446849
(ClinicalTrials.gov)
May 1, 200712/3/2007Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)A Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC)Ulcerative ColitisDrug: MMX MesalamineShireNULLCompleted18 YearsN/AAll290Phase 4United States
81NCT00343850
(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
82EUCTR2006-001310-32-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
83NCT00349388
(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
84EUCTR2006-001310-32-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
85EUCTR2006-001310-32-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
86EUCTR2006-001310-32-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
87NCT00350415
(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
88NCT00408174
(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
89EUCTR2006-001310-32-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
90NCT00326209
(ClinicalTrials.gov)
December 22, 200512/5/2006Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in RemissionA Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet FormulationUlcerative ColitisDrug: Encapsulated Mesalamine Granules (eMG)Bausch Health Americas, Inc.NULLCompleted18 YearsN/AAll393Phase 3United States
91NCT00254618
(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
92NCT00746447
(ClinicalTrials.gov)
May 20053/9/2008Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative ColitisColitis, Ulcerative;RecurrenceDrug: mesalamine granulesDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth648Phase 3Germany
93NCT00744016
(ClinicalTrials.gov)
December 200427/8/2008Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative ColitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: Granulated mesalamine;Drug: PlaceboBausch Health Americas, Inc.NULLCompleted18 YearsN/AAll305Phase 3United States
94NCT00767728
(ClinicalTrials.gov)
December 200417/9/2008Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative ColitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: Granulated mesalamine;Drug: PlaceboBausch Health Americas, Inc.NULLCompleted18 YearsN/AAll256Phase 3United States
95EUCTR2004-000611-25-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
96EUCTR2004-000611-25-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
97NCT00194818
(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
98NCT00577473
(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
99NCT00073021
(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

98. 好酸球性消化管疾患


臨床試験数 : 172 薬物数 : 149 - (DrugBank : 39) / 標的遺伝子数 : 38 - 標的パスウェイ数 : 135
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05488405
(ClinicalTrials.gov)
February 9, 20223/8/2022Mesalazine Oral Suspension in Active Eosinophilic EsophagitisOpen-label, Monocentric Phase IIa Pilot Study Evaluating the Efficacy and Tolerability of a 4-week Treatment With Mesalazine Oral Suspension in Patients With Active Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Mesalamine Oral ProductDr. Falk Pharma GmbHNULLRecruiting18 Years75 YearsAll10Phase 2Switzerland

164. 眼皮膚白皮症


臨床試験数 : 15 薬物数 : 54 - (DrugBank : 34) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00514982
(ClinicalTrials.gov)
August 7, 20079/8/2007Medical Treatment of Colitis in Patients With Hermansky-Pudlak SyndromeAn Observational Study of the Immunopathogenesis of and Response to Step-Up Inflammatory Bowel Disease Therapy for Hermansky-Pudlak Syndrome-Associated ColitisHermanski-Pudlak Syndrome;Colitis;Cytokines;Lymphocytes;Drug EvaluationDrug: Mesalamine;Drug: Infliximab;Drug: Corticosteroids;Drug: 6-Mercaptopurine;Drug: Tacrolimus;Drug: AdalimumabNational Institute of Allergy and Infectious Diseases (NIAID)NULLWithdrawn18 YearsN/AAll0Phase 2United States