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

Bristol-Myers Squibb39 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

PlaceboDRUG

Tablets, Oral, once daily, 2 weeks

BMS-562086DRUG

Tablets, Oral, once daily, 2 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit

Time frame: taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16

Secondary Outcomes

Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms.

Time frame: throughout the study

Safety

Time frame: Safety labs at screening, nominal study days -3, 8, 15, 42, and 70 (discharge). ECGs will be taken at screening, nominal days 5 or 6, 14, and discharge. Vital signs will be taken at screening, on nominal days 3, 4, 5, 7, 8, 10, 11, 42 and discharge

Blood pharmacokinetics

Time frame: PK samples will be taken on nominal days 8, 14 (serial: predose 0.5, 1, 2, 4, 6, 9 hours post dose), 15 (pre dose and 9 hours post dose), 16, 42 and discharge

Data from ClinicalTrials.gov

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