An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

NCT00463151 | Completed Phase 2 Results

• 2 other identifiers: 037-06-001JapicCTI-070399
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 5

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

Keywords

Rebamipide; Enema; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Week 6

• Mean Change From Baseline in Total DAI Score

  Baseline and Week 6

• Percentage of Subjects Showing Improvement in Each DAI Subscore

  Baseline and week 6

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

  Baseline and Week 6

Study Arms (4)

1

PLACEBO COMPARATOR

0mg rebamipide

Drug: rebamipide

2

EXPERIMENTAL

60mg rebamipide

Drug: rebamipide

3

EXPERIMENTAL

150mg rebamipide

Drug: rebamipide

4

EXPERIMENTAL

300mg rebamipide

Drug: rebamipide

Interventions

rebamipide DRUG

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

1; 2; 3; 4

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

rebamipide

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Katsuhisa Saito

  Division of New Product Evaluation and Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 20, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 20, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-06

Locations

JP (5)