A Study of BMS-562086 in Patients With Irritable Bowel Syndrome
- Registration Number
- NCT00399438
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo 0 mg 2 BMS-562086 25 mg 3 BMS-562086 100 mg
- Primary Outcome Measures
Name Time Method Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16
- Secondary Outcome Measures
Name Time Method Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms. throughout the study Safety 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 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
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States