An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Sponsors

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Source Otsuka Pharmaceutical Co., Ltd.
Brief 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).

Overall Status Completed
Start Date June 2007
Completion Date February 2009
Primary Completion Date February 2009
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical improvement rate (Clinical improvement: a decrease of Disease Activity Index [DAI] score for "bloody stools" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "endoscopic findings" from the baseline) 6 weeks
Secondary Outcome
Measure Time Frame
Clinical remission: a decrease of the total DAI scores for "bloody stools" and "endoscopic findings" to 0 points 6weeks
Changes in the total DAI score 6 weeks
Changes in each DAI subscore 2, 4, 6weeks
Changes in the total Endoscopic Index (EI) score 6 weeks
Changes in each EI subscore 6 weeks
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: rebamipide

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

Eligibility

Criteria:

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

Gender: All

Minimum Age: 16 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Katsuhisa Saito Study Director Division of New Product Evaluation and Development
Location
Facility:
| Chubu region, Japan
| Chugoku region, Japan
| Hokkaido region, Japan
| Kinki region, Japan
| Kyushu region, Japan
Location Countries

Japan

Verification Date

February 2011

Responsible Party

Name Title: Saito Katsuhisa

Organization: OPCJ

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: 1

Type: Placebo Comparator

Description: 0mg rebamipide

Label: 2

Type: Experimental

Description: 60mg rebamipide

Label: 3

Type: Experimental

Description: 150mg rebamipide

Label: 4

Type: Experimental

Description: 300mg rebamipide

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov