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A Study of BMS-562086 in Patients With Irritable Bowel Syndrome

NCT ID: NCT00399438

Last Updated: 2008-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-01-31

Brief Summary

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The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome (D-IBS)

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Keywords

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Diarrhea-predominant irritable bowel syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

0 mg

Group Type OTHER

Placebo

Intervention Type DRUG

Tablets, Oral, once daily, 2 weeks

2

25 mg

Group Type OTHER

BMS-562086

Intervention Type DRUG

Tablets, Oral, once daily, 2 weeks

3

100 mg

Group Type OTHER

BMS-562086

Intervention Type DRUG

Tablets, Oral, once daily, 2 weeks

Interventions

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Placebo

Tablets, Oral, once daily, 2 weeks

Intervention Type DRUG

BMS-562086

Tablets, Oral, once daily, 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire

Exclusion Criteria

* Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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CN148-013

Identifier Type: -

Identifier Source: org_study_id