Clinical Trial: A Study of BMS-562086 in Patients With Irritable Bowel Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Dose-Ranging Study of the Pharmacodynamic Effects of BMS-562086 on Gastrointestinal Transit in Women With Diarrhea-Predominant Irritable Bowel Syndrome
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 Summary:
Sponsor: Bristol-Myers Squibb
Current Primary Outcome: 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 ]
Original Primary Outcome: Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms. Measurements of safety and blood pharmacokinetics will also be collected
Information By: Bristol-Myers Squibb
Dates:
Date Received: November 13, 2006
Date Started: December 2006
Date Completion:
Last Updated: September 25, 2008
Last Verified: September 2008
