Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00463151 | An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis | PHASE2 | COMPLETED | 124 | — | — | Jun 1, 2007 | Aug 1, 2008 | Jul 20, 2021 | 5 | Japan |
Definition of clinical improvement: a decrease of Disease Activity Index \[DAI\] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | 0mg rebamipide |
| 2 | EXPERIMENTAL | 60mg rebamipide |
| 3 | EXPERIMENTAL | 150mg rebamipide |
| 4 | EXPERIMENTAL | 300mg rebamipide |
| Name | Type | Description |
|---|---|---|
| rebamipide | DRUG | 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon |
Inclusion Criteria: 1. Patients with active ulcerative colitis 2. Patients having an insufficient response to ASA oral formulation: (1) Patients whose ongoing use of ASA oral formulation from ≥2 weeks prior to the day before registration is fixed at mesalazine ≥2 g/day or salazosulfapyridine 3-6 g/...