Phase 2
N=124
An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Colitis, Ulcerative
Bottom Line
View on ClinicalTrials.gov: NCT00463151 ↗Enrolled (actual)
124
Serious AEs
2.4%
Results posted
Jul 2021
Primary outcome: Primary: Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) — 31.4; 24.1; 44.4; 30.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rebamipide (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) |
31.4; 24.1; 44.4; 30.0 | — |
| SECONDARY Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) |
2.9; 0.0; 18.5; 3.3 | — |
| SECONDARY Mean Change From Baseline in Total DAI Score |
-2.5; -1.6; -3.0; -2.0 | — |
| SECONDARY Percentage of Subjects Showing Improvement in Each DAI Subscore |
48.6; 31.0; 59.3; 10.0; 65.7; 51.7 | — |
| SECONDARY Mean Change From Baseline in Total Endoscopic Index (EI) Score |
-1.6; -1.2; -2.4; -1.9 | — |
Summary
The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).
Eligibility Criteria
Inclusion Criteria
- Patients with active ulcerative colitis
- 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/day, (2) Patients with continuous bloody stools from ≥2 weeks prior to the day before registration, (3) Patients whose DAI subscores are ≥2 points for "bloody stools" and ≥2 points for "endoscopic findings"
- Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure)
- Outpatients
Exclusion Criteria
- Patients who have a history of intestinal resection (other than appendiceal resection)
- Patients who have a complication of malignant tumor
- Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period
- Patients who have complications of serious cardiac, hepatic or renal impairment
Data sourced from ClinicalTrials.gov (NCT00463151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.