97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-001644-10-IT (EUCTR) | 21/12/2021 | 17/09/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis(EXPEDITION OLE) - EXPEDITION OLE | 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: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 2 | NCT05084261 (ClinicalTrials.gov) | November 30, 2021 | 20/9/2021 | An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) | A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: BT051 200 mg;Drug: BT051 800 mg;Drug: BT051 3200 mg;Drug: BT051 up to 3200 mg;Drug: Matching Placebo | Bacainn Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 44 | Phase 1 | United States;Georgia;Moldova, Republic of;Poland;Ukraine |
| 3 | NCT04457960 (ClinicalTrials.gov) | July 1, 2020 | 1/7/2020 | A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis | A 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-66525433 | Healthy;Colitis, Ulcerative | Drug: JNJ-66525433;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 60 Years | All | 140 | Phase 1 | Georgia;Germany;Moldova, Republic of |
| 4 | NCT04224857 (ClinicalTrials.gov) | April 1, 2019 | 23/5/2019 | SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101 | A 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-101 | Ulcerative Colitis | Drug: AMT-101;Drug: Placebos | Applied Molecular Transport | NULL | Completed | 18 Years | N/A | All | 52 | Phase 1 | Georgia;Germany;Moldova, Republic of;Ukraine |
| 5 | NCT03482648 (ClinicalTrials.gov) | March 20, 2018 | 17/3/2018 | First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers | A 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 Subjects | Ulcerative Colitis | Drug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: Placebo | Bridge Biotherapeutics, Inc. | KCRN Research, LLC | Completed | 19 Years | 55 Years | All | 80 | Phase 1 | United States |
| 6 | NCT03103412 (ClinicalTrials.gov) | May 4, 2017 | 24/3/2017 | TD-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 Subjects | Drug: TD-3504;Drug: 15N2-tofacitinib;Drug: Placebo | Theravance Biopharma | NULL | Completed | 18 Years | 55 Years | All | 32 | Phase 1 | United States |
| 7 | NCT03071081 (ClinicalTrials.gov) | February 8, 2017 | 20/2/2017 | Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy Subjects | A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy Volunteers | Ulcerative Colitis | Drug: TOP1288;Drug: Placebo to TOP1288 | Topivert Pharma Ltd | NULL | Completed | 18 Years | 55 Years | Male | 37 | Phase 1 | United Kingdom |
| 8 | NCT03038711 (ClinicalTrials.gov) | February 1, 2017 | 26/1/2017 | A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers | A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects | Ulcerative Colitis | Drug: BMS-986166;Other: Placebo matching BMS-986166 | Bristol-Myers Squibb | NULL | Completed | 18 Years | 55 Years | All | 213 | Phase 1 | United States |
| 9 | NCT02864264 (ClinicalTrials.gov) | September 14, 2016 | 9/8/2016 | Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis | Double-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 Colitis | Healthy Volunteers;Ulcerative Colitis | Drug: BMS-986184;Drug: Placebo matching BMS-986184 | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 75 Years | All | 7 | Phase 1 | Australia;Georgia;Moldova, Republic of;Romania |
| 10 | NCT02647866 (ClinicalTrials.gov) | June 2016 | 8/12/2015 | Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis | A 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 UC | Ulcerative Colitis;Digestive System Diseases;Colitis, Ulcerative;Colitis;Gastrointestinal Diseases;Inflammatory Bowel Diseases;Intestinal Diseases;Colonic Diseases;Autoimmune Disease;Abdominal Pain | Drug: KHK4083;Drug: Placebo | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 18 Years | N/A | All | 66 | Phase 2 | United States;Czechia;Hungary;Poland;Romania;Russian Federation;Serbia;Czech Republic;Puerto Rico |
| 11 | EUCTR2015-001555-69-PL (EUCTR) | 28/04/2016 | 22/12/2015 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation | ||
| 12 | NCT02749630 (ClinicalTrials.gov) | April 11, 2016 | 12/4/2016 | A 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 Disease | Ulcerative Colitis;Crohn's Disease | Drug: Placebo;Drug: UTTR1147A | Genentech, Inc. | NULL | Completed | 18 Years | 80 Years | All | 70 | Phase 1 | Germany;United Kingdom;Canada |
| 13 | EUCTR2015-001555-69-CZ (EUCTR) | 07/03/2016 | 14/12/2015 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation | ||
| 14 | NCT02818543 (ClinicalTrials.gov) | March 2016 | 30/3/2016 | Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis | An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: LYC-30937 | Lycera Corp. | NULL | Completed | 18 Years | 75 Years | Both | 6 | Phase 1 | Hungary |
| 15 | EUCTR2015-001555-69-HU (EUCTR) | 15/01/2016 | 17/11/2015 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation | ||
| 16 | NCT02463045 (ClinicalTrials.gov) | May 2015 | 26/5/2015 | Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis Subjects | A 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 Colitis | Ulcerative Colitis | Drug: TOP1288 | Topivert Pharma Ltd | NULL | Completed | 18 Years | 55 Years | All | 67 | Phase 1 | United Kingdom |
| 17 | NCT01929668 (ClinicalTrials.gov) | August 2013 | 23/8/2013 | Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients | Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter Study | Ulcerative Colitis | Drug: polyethylene glycol;Drug: Ascorbic Acid | Kyungpook National University | NULL | Completed | 18 Years | 80 Years | Both | 114 | N/A | Korea, Republic of |
| 18 | NCT01914887 (ClinicalTrials.gov) | June 2013 | 18/7/2013 | Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis | A 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 | Ulcerative Colitis | Drug: Allogeneic adipose tissue-derived mesenchymal stem cells | Instituto de Investigación Hospital Universitario La Paz | Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz;Ministry of Health, Spain | Recruiting | 18 Years | N/A | Both | 8 | Phase 1/Phase 2 | Spain |
| 19 | NCT01831427 (ClinicalTrials.gov) | March 2013 | 8/4/2013 | Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative Colitis | A 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 Colitis | Ulcerative Colitis | Drug: GS-5745;Drug: Placebo to match GS-5745 | Gilead Sciences | NULL | Completed | 18 Years | 65 Years | All | 74 | Phase 1 | United States;Belgium;Canada;Hungary;Moldova, Republic of;Netherlands;Romania |
| 20 | NCT01759056 (ClinicalTrials.gov) | February 2013 | 24/12/2012 | Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis | A 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 Colitis | Ulcerative Colitis | Drug: AVX 470;Drug: Placebo | Avaxia Biologics, Incorporated | NULL | Completed | 18 Years | 75 Years | Both | 33 | Phase 1 | United States;Belgium;Canada;Hungary |
| 21 | NCT02922374 (ClinicalTrials.gov) | January 2013 | 28/9/2016 | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study | Acute Severe Colitis (ASC) | Drug: corticosteroids | Jinling Hospital, China | NULL | Active, not recruiting | 18 Years | N/A | Both | 117 | Phase 1/Phase 2 | China |
| 22 | EUCTR2010-023798-20-ES (EUCTR) | 29/11/2012 | 10/05/2012 | A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITIS | A 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 Paz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1/2 | Spain | |||
| 23 | EUCTR2010-023494-19-SE (EUCTR) | 10/02/2011 | 27/12/2010 | A 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 | A 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 Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Sweden | ||
| 24 | NCT01290042 (ClinicalTrials.gov) | February 2011 | 27/1/2011 | Study 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 Disease | Drug: AMG 181;Other: Placebo for AMG 181 | Amgen | NULL | Completed | 18 Years | 65 Years | Both | 43 | Phase 1 | United States;Australia |
| 25 | NCT01164904 (ClinicalTrials.gov) | July 2010 | 1/7/2010 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis | A 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 Colitis | Ulcerative Colitis | Drug: Amg 181 | Amgen | NULL | Terminated | 18 Years | 55 Years | Both | 72 | Phase 1 | United States;Australia;New Zealand |
| 26 | NCT01149694 (ClinicalTrials.gov) | June 2009 | 22/6/2010 | A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers | A Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy Volunteers | Ulcerative Colitis | Drug: PUR 0110 Rectal Enema or Placebo Enema | PurGenesis Technologies Inc. | NULL | Completed | 18 Years | 55 Years | Male | 24 | Phase 1 | Germany |
| 27 | EUCTR2006-001310-32-LT (EUCTR) | 17/07/2006 | 15/05/2006 | A 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 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 28 | EUCTR2006-001310-32-HU (EUCTR) | 29/06/2006 | 23/05/2006 | A 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 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 29 | EUCTR2006-001310-32-CZ (EUCTR) | 26/06/2006 | 17/05/2006 | A 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 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 30 | EUCTR2006-001310-32-EE (EUCTR) | 16/06/2006 | 27/04/2006 | A 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 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 31 | EUCTR2006-001310-32-LV (EUCTR) | 28/04/2006 | 22/08/2006 | A 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 | A 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 | Product Name: Asacol 800mg tablet INN or Proposed INN: mesalazine Product Name: Asacol 400mg tablet INN or Proposed INN: mesalazine | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 470 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 32 | NCT00577473 (ClinicalTrials.gov) | February 2001 | 19/12/2007 | Safety 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/Day | Ulcerative Colitis | Drug: mesalamine | Warner Chilcott | NULL | Completed | 18 Years | 65 Years | All | 301 | Phase 3 | United States |