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Clinical Trials/JPRN-jRCT2080220390
JPRN-jRCT2080220390CompletedPhase 2

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Otsuka Pharmaceutical Co., Ltd.0 sites124 target enrollmentStarted: May 21, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
124
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 16age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Investigators

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