At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 124 enrolled
Drug / intervention
rebamipidedrug
Likely dose
rebamipide 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating rebamipide for Colitis, Ulcerative. Completed, enrolled 124 participants across 5 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2007
Enrollment StartJun 2007
Primary CompletionAug 2008
TodayJul 2026
First PostedApr 20, 2007
Enrollment StartJun 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.2 years ago
Interventions
rebamipidedrug
0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon