5 completed, 3 terminated. 5 Phase 2, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Terminated 3, Completed 2 |
| Phase 3 | 4 | Completed 4 |
Follow tetomilast: new trials by email Literature Review of tetomilast trials Research Report on tetomilast
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease Placebo, OPC-6535 - Crohn's Disease | Phase 2 / Phase 3 | Completed | Otsuka Pharmaceutical Co., Ltd. | 191 | 2009-10-01 | 2021-04-06 |
| To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients tetomilast (OPC-6535), placebo - Chronic Obstructive Pulmonary Disease | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 771 | 2009-03-01 | 2021-04-30 |
| Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema tetomilast, placebo - Chronic Obstructive Pulmonary Disease | Phase 2 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 84 | 2009-03-01 | 2017-04-17 |
| A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease OPC-6535(Tetomilast) - Crohn Disease | Phase 2 | Terminated | Otsuka Pharmaceutical Co., Ltd. | 29 | 2006-05-01 | 2021-02-15 |
| A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis OPC-6535(Tetomilast) - Colitis, Ulcerative | Phase 2 | Terminated | Otsuka Pharmaceutical Co., Ltd. | 43 | 2006-05-01 | 2021-04-30 |
| CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission OPC-6535, Asacol® - Ulcerative Colitis | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1725 | 2004-05-01 | 2007-06-21 |
| FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis OPC-6535 Tablets (drug) - Ulcerative Colitis | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 375 | 2003-05-01 | 2012-05-10 |
| FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis OPC-6535 Tablets (drug) - Ulcerative Colitis | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 375 | 2003-05-01 | 2012-05-10 |
Colitis, Ulcerative (4) · Crohn Disease (2) · Pulmonary Disease, Chronic Obstructive (2) · Colitis (1) · Emphysema (1) · Hemorrhage (1) · Recurrence (1) · Ulcer (1)
Otsuka Pharmaceutical Co., Ltd. (4) · Otsuka Pharmaceutical Development & Commercialization, Inc. (4)
Japan (4) · United States (4) · South Korea (2) · China (1)
Katsuhisa Saito (3)