97. Ulcerative colitis
2,269 clinical trials,   1,331 drugs   (DrugBank: 241 drugs),   114 drug target genes,   181 drug target pathways

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

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
30 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
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Inclusion_
agemin
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agemax
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PhaseCountries
1NCT04457960
(ClinicalTrials.gov)
July 1, 20201/7/2020A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative ColitisA Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433Healthy;Colitis, UlcerativeDrug: JNJ-66525433;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 Years60 YearsAll128Phase 1Georgia;Germany;Moldova, Republic of
2NCT04224857
(ClinicalTrials.gov)
April 1, 201923/5/2019SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101Ulcerative ColitisDrug: AMT-101;Drug: PlacebosApplied Molecular TransportNULLCompleted18 YearsN/AAll52Phase 1Georgia;Germany;Moldova, Republic of;Ukraine
3NCT03482648
(ClinicalTrials.gov)
March 20, 201817/3/2018First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy VolunteersA Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult SubjectsUlcerative ColitisDrug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: PlaceboBridge Biotherapeutics, Inc.KCRN Research, LLCCompleted19 Years55 YearsAll80Phase 1United States
4NCT03103412
(ClinicalTrials.gov)
May 4, 201724/3/2017TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsDrug: TD-3504;Drug: 15N2-tofacitinib;Drug: PlaceboTheravance BiopharmaNULLCompleted18 Years55 YearsAll32Phase 1United States
5NCT03071081
(ClinicalTrials.gov)
February 8, 201720/2/2017Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy SubjectsA Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy VolunteersUlcerative ColitisDrug: TOP1288;Drug: Placebo to TOP1288Topivert Pharma LtdNULLCompleted18 Years55 YearsMale37Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03038711
(ClinicalTrials.gov)
February 1, 201726/1/2017A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy VolunteersA Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy SubjectsUlcerative ColitisDrug: BMS-986166;Other: Placebo matching BMS-986166Bristol-Myers SquibbNULLCompleted18 Years55 YearsAll213Phase 1United States
7NCT02864264
(ClinicalTrials.gov)
September 14, 20169/8/2016Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative ColitisDouble-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative ColitisHealthy Volunteers;Ulcerative ColitisDrug: BMS-986184;Drug: Placebo matching BMS-986184Bristol-Myers SquibbNULLTerminated18 Years75 YearsAll7Phase 1Australia;Georgia;Moldova, Republic of;Romania
8NCT02647866
(ClinicalTrials.gov)
June 20168/12/2015Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) & Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderately Active UCUlcerative Colitis;Digestive System Diseases;Colitis, Ulcerative;Colitis;Gastrointestinal Diseases;Inflammatory Bowel Diseases;Intestinal Diseases;Colonic Diseases;Autoimmune Disease;Abdominal PainDrug: KHK4083;Drug: PlaceboKyowa Kirin Pharmaceutical Development, Inc.NULLCompleted18 YearsN/AAll66Phase 2United States;Czechia;Hungary;Poland;Romania;Russian Federation;Serbia;Czech Republic;Puerto Rico
9EUCTR2015-001555-69-PL
(EUCTR)
28/04/201622/12/2015A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
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: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation
10NCT02749630
(ClinicalTrials.gov)
April 11, 201612/4/2016A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: Placebo;Drug: UTTR1147AGenentech, Inc.NULLCompleted18 Years80 YearsAll70Phase 1Germany;United Kingdom;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
11EUCTR2015-001555-69-CZ
(EUCTR)
07/03/201614/12/2015A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
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: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation
12NCT02818543
(ClinicalTrials.gov)
March 201630/3/2016Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative ColitisAn Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: LYC-30937Lycera Corp.NULLCompleted18 Years75 YearsBoth6Phase 1Hungary
13EUCTR2015-001555-69-HU
(EUCTR)
15/01/201617/11/2015A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
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: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation
14NCT02463045
(ClinicalTrials.gov)
May 201526/5/2015Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis SubjectsA Phase I Study to Evaluate the Safety/Tolerability and Pharmacokinetics of TOP1288 Rectal Single and Multiple Ascending Doses in Healthy Subjects and Multiple Doses in Subjects With Ulcerative ColitisUlcerative ColitisDrug: TOP1288Topivert Pharma LtdNULLCompleted18 Years55 YearsAll67Phase 1United Kingdom
15NCT01929668
(ClinicalTrials.gov)
August 201323/8/2013Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC PatientsComparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter StudyUlcerative ColitisDrug: polyethylene glycol;Drug: Ascorbic AcidKyungpook National UniversityNULLCompleted18 Years80 YearsBoth114N/AKorea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
16NCT01914887
(ClinicalTrials.gov)
June 201318/7/2013Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative ColitisA Phase I/IIa Clinical Trial to Evaluate Safety and Efficacy of Adipose Tissue-derived Mesenchymal Stem Cells (ASC) on Induction to Remission in Ulcerative ColitisUlcerative ColitisDrug: Allogeneic adipose tissue-derived mesenchymal stem cellsInstituto de Investigación Hospital Universitario La PazFundacion para la Investigacion Biomedica del Hospital Universitario la Paz;Ministry of Health, SpainRecruiting18 YearsN/ABoth8Phase 1;Phase 2Spain
17NCT01831427
(ClinicalTrials.gov)
March 20138/4/2013Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative ColitisA Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: GS-5745;Drug: Placebo to match GS-5745Gilead SciencesNULLCompleted18 Years65 YearsAll74Phase 1United States;Belgium;Canada;Hungary;Moldova, Republic of;Netherlands;Romania
18NCT01759056
(ClinicalTrials.gov)
February 201324/12/2012Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative ColitisA Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: AVX 470;Drug: PlaceboAvaxia Biologics, IncorporatedNULLCompleted18 Years75 YearsBoth33Phase 1United States;Belgium;Canada;Hungary
19NCT02922374
(ClinicalTrials.gov)
January 201328/9/2016Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative ColitisUlcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational StudyAcute Severe Colitis (ASC)Drug: corticosteroidsJinling Hospital, ChinaNULLActive, not recruiting18 YearsN/ABoth117Phase 1;Phase 2China
20EUCTR2010-023798-20-ES
(EUCTR)
29/11/201210/05/2012A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITISA PHASE I/IIA CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (ASC) ON INDUCTION TO REMISSION IN ULCERATIVE COLITIS - ALOASCU
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ASC
INN or Proposed INN: adipose tissue-derived mesenchymal stem cells
Other descriptive name: aloASC
Fundacion para la Investigacion Biomedica Hospital Universitario La PazNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 1;Phase 2ASpain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2010-023494-19-SE
(EUCTR)
10/02/201127/12/2010A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative ColitisA Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Lysine-D-Proline-Threonine
Product Code: K(D)PT
Dr. August Wolff GmbH & Co. KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Sweden
22NCT01290042
(ClinicalTrials.gov)
February 201127/1/2011Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.Ulcerative Colitis;Crohn's DiseaseDrug: AMG 181;Other: Placebo for AMG 181AmgenNULLCompleted18 Years65 YearsBoth43Phase 1United States;Australia
23NCT01164904
(ClinicalTrials.gov)
July 20101/7/2010Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative ColitisA Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: Amg 181AmgenNULLTerminated18 Years55 YearsBoth72Phase 1United States;Australia;New Zealand
24NCT01149694
(ClinicalTrials.gov)
June 200922/6/2010A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy VolunteersA Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy VolunteersUlcerative ColitisDrug: PUR 0110 Rectal Enema or Placebo EnemaPurGenesis Technologies Inc.NULLCompleted18 Years55 YearsMale24Phase 1Germany
25EUCTR2006-001310-32-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-001310-32-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
27EUCTR2006-001310-32-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
28EUCTR2006-001310-32-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
29EUCTR2006-001310-32-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
30NCT00577473
(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