An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Otsuka Pharmaceutical Co., Ltd.124 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

124

Conditions

Colitis, Ulcerative

Interventions

rebamipideDRUG

0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with active ulcerative colitis 2. 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" 3. Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure) 4. Outpatients 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

Locations (5)

Unnamed facility

Chubu Region, Japan

Unnamed facility

Chugoku Region, Japan

Unnamed facility

Hokkaido Region, Japan

Unnamed facility

Kinki Region, Japan

Unnamed facility

Kyushu Region, Japan

Outcomes

Primary Outcomes

Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)

Definition of clinical improvement: a decrease of Disease Activity Index \[DAI\] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline

Time frame: Week 6

Secondary Outcomes

Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)

Definition of remission: a decrease of the total DAI scores for "rectal bleeding" and "findings on endoscopy" to 0 points

Time frame: Week 6

Mean Change From Baseline in Total DAI Score

DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement.

Time frame: Baseline and Week 6

Percentage of Subjects Showing Improvement in Each DAI Subscore

DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change from baseline indicates improvement.

Time frame: Baseline and week 6

Mean Change From Baseline in Total Endoscopic Index (EI) Score

The index consisted of 4 subscales: granulation scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage. Each subscale was scored on a scale of 0 to 4 and the total score (the sum of all 4 subscores) ranges from 0 to 12, higher scores indicate more severe disease.

Data from ClinicalTrials.gov

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