An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

Official title:

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463151
• Other study ID #: 037-06-001
• Secondary ID: JapicCTI-070399
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: August 2008

Study information

• Verified date: June 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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