An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
- Conditions
- Active ulcerative colitis
- Registration Number
- JPRN-jRCT2080220390
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Clinical improvement rate, the primary endpoint, in the rebamipide 60-mg, 150-mg, and 300-mg groups was respectively 31.4%, 24.1%, and 44.4% versus 30.0% in the placebo group. This result showed no evident efficacy or dose-dependency for rebamipide within the dose range of up to 300 mg. No particular safety concerns emerged at any dose studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 124
1)Patients aged 16 years or older
2)Patients having an insufficient response to ASA oral formulation
3)Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum
1. Patients who have a history of intestinal resection (other than appendiceal resection)
2. Patients who have a complication of malignant tumor
3. Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period
4. Patients who have complications of serious cardiac, hepatic or renal impairment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Efficacy: Clinical improvement rate, Safety: Adverse events
- Secondary Outcome Measures
Name Time Method efficacy<br>- Clinical remission: a decrease of the total Disease Activity Index [DAI] scores for bloody stools and endoscopic findings to 0 points [Time Frame: 6weeks] <br>- Changes in the total DAI score [Time Frame: 6 weeks] <br>- Changes in each DAI subscore [Time Frame: 2, 4, 6weeks] <br>- Changes in the total Endoscopic Index (EI) score [Time Frame: 6 weeks] <br>- Changes in each EI subscore [Time Frame: 6 weeks]