Trials Sponsors Conditions Drugs Pricing

Conditions

Colitis, Ulcerative

Keywords

RebamipideEnemaUlcerative 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

Interventions

rebamipideDrug

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

1234

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (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"

Sponsors & Collaborators

Otsuka Pharmaceutical Co., Ltd.
Industrylead

Study Sites (5)

Chubu Region, Japan

Chugoku Region, Japan

Hokkaido Region, Japan

Kinki Region, Japan

Kyushu Region, Japan

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

rebamipide

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

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

Study Officials

Katsuhisa Saito
Division of New Product Evaluation and Development
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

124 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations