An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

NCT ID: NCT00463151

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-08-31

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).

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

0mg rebamipide

Group Type: PLACEBO_COMPARATOR

rebamipide

Intervention Type: DRUG

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

2

60mg rebamipide

Group Type: EXPERIMENTAL

rebamipide

Intervention Type: DRUG

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

3

150mg rebamipide

Group Type: EXPERIMENTAL

rebamipide

Intervention Type: DRUG

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

4

300mg rebamipide

Group Type: EXPERIMENTAL

rebamipide

Intervention Type: DRUG

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

Interventions

rebamipide

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

OPCJ

Principal Investigators

Katsuhisa Saito

Role: STUDY_DIRECTOR

Division of New Product Evaluation and Development

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Countries

Japan

Other Identifiers

JapicCTI-070399

Identifier Type: OTHER

Identifier Source: secondary_id

037-06-001

Identifier Type: -

Identifier Source: org_study_id