Opc-6535 (DrugBank: -)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 96 | Crohn disease | 2 |
| 97 | Ulcerative colitis | 8 |
| 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 | NCT00989573 (ClinicalTrials.gov) | October 2009 | 2/10/2009 | A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease | A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: OPC-6535 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | 64 Years | Both | 191 | Phase 2;Phase 3 | Japan;Korea, Republic of |
| 2 | NCT00317369 (ClinicalTrials.gov) | May 2006 | 21/4/2006 | A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease | A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease | Crohn Disease | Drug: OPC-6535(Tetomilast) | Otsuka Pharmaceutical Co., Ltd. | NULL | Terminated | 16 Years | 65 Years | Both | 60 | Phase 2 | Japan |
| 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 | NCT00317356 (ClinicalTrials.gov) | May 2006 | 21/4/2006 | A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis | A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: OPC-6535(Tetomilast) | Otsuka Pharmaceutical Co., Ltd. | NULL | Terminated | 18 Years | 65 Years | Both | 160 | Phase 2 | Japan |
| 2 | EUCTR2005-003724-19-CZ (EUCTR) | 21/11/2005 | 05/10/2005 | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | Active Ulcerative Colitis MedDRA version: 8.0;Level: LLT;Classification code 10058816 | Product Name: OPC-6535 Product Code: OPC-6535 INN or Proposed INN: Not applicable Other descriptive name: OPC-6535 | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 3 | Hungary;Czech Republic | ||
| 3 | EUCTR2005-003724-19-HU (EUCTR) | 24/10/2005 | 07/09/2005 | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | Active Ulcerative Colitis MedDRA version: 8.0;Level: LLT;Classification code 10058816 | Product Name: OPC-6535 Product Code: OPC-6535 INN or Proposed INN: Not applicable Other descriptive name: OPC-6535 | Otsuka Maryland Research Institute, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 3 | Hungary | ||
| 4 | EUCTR2004-000611-25-IE (EUCTR) | 19/10/2004 | 16/08/2004 | A 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 | A 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 colitis | Product 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. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 5 | EUCTR2004-000611-25-HU (EUCTR) | 15/10/2004 | 21/07/2004 | A 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 | A 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 colitis | Product 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. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 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 |
| 6 | NCT00092508 (ClinicalTrials.gov) | May 2004 | 22/9/2004 | CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission | Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission | Ulcerative Colitis | Drug: OPC-6535;Drug: Asacol® | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 1725 | Phase 3 | United States |
| 7 | NCT00064454 (ClinicalTrials.gov) | May 2003 | 8/7/2003 | FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis | FACTS II: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: OPC-6535 Tablets (drug) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 375 | Phase 3 | United States |
| 8 | NCT00064441 (ClinicalTrials.gov) | May 2003 | 8/7/2003 | FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis | FACTS I: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: OPC-6535 Tablets (drug) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 375 | Phase 3 | United States |