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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Placebo; Drug: BMS-562086

Study type: Interventional

Funder types: Industry

Identifiers

NCT00399438

CN148-013

Details and patient eligibility

About

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)

Enrollment: 39 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

39 participants in 3 patient groups

1

Other group

Description:

0 mg

Treatment:

Drug: Placebo

2

Other group

Description:

25 mg

Treatment:

Drug: BMS-562086

3

Other group

Description:

100 mg

Treatment:

Drug: BMS-562086