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An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
rebamipide
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Rebamipide, Enema, Ulcerative Colitis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

0mg rebamipide

60mg rebamipide

150mg rebamipide

300mg rebamipide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
April 19, 2007
Last Updated
June 30, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00463151
Brief Title
An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Official Title
An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
Rebamipide, Enema, Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
0mg rebamipide
Arm Title
2
Arm Type
Experimental
Arm Description
60mg rebamipide
Arm Title
3
Arm Type
Experimental
Arm Description
150mg rebamipide
Arm Title
4
Arm Type
Experimental
Arm Description
300mg rebamipide
Intervention Type
Drug
Intervention Name(s)
rebamipide
Intervention Description
0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
Primary Outcome Measure Information:
Title
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)
Description
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
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)
Description
Definition of remission: a decrease of the total DAI scores for "rectal bleeding" and "findings on endoscopy" to 0 points
Time Frame
Week 6
Title
Mean Change From Baseline in Total DAI Score
Description
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.
Time Frame
Baseline and Week 6
Title
Percentage of Subjects Showing Improvement in Each DAI Subscore
Description
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.
Time Frame
Baseline and week 6
Title
Mean Change From Baseline in Total Endoscopic Index (EI) Score
Description
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.
Time Frame
Baseline and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
Division of New Product Evaluation and Development
Official's Role
Study Director
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Hokkaido region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushu Region
Country
Japan

12. IPD Sharing Statement

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An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

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