drugset / Trial / NCT00463151

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

NCT00463151

Phase 2 Completed 124 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2007-06
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Rebamipide Small molecule 60 mg Other
Subject Rebamipide Small molecule 150 mg Other
Subject Rebamipide Small molecule 300 mg Other

Indications