An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Study Overview
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Brief Summary
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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).

Official Title
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An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: rebamipide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with active ulcerative colitis 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 Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure) Outpatients Exclusion Criteria: Patients who have a history of intestinal resection (other than appendiceal resection) Patients who have a complication of malignant tumor Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period Patients who have complications of serious cardiac, hepatic or renal impairment

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>0mg rebamipide | Drug: rebamipide<br>* 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon<br>|
| Experimental: 2<br>60mg rebamipide | Drug: rebamipide<br>* 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon<br>|
| Experimental: 3<br>150mg rebamipide | Drug: rebamipide<br>* 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon<br>|
| Experimental: 4<br>300mg rebamipide | Drug: rebamipide<br>* 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | Baseline and Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rebamipide, Enema, Ulcerative Colitis