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NCT Number: NCT00399438

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

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)

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Tablets, Oral, once daily, 2 weeks

BMS-562086

Drug

Tablets, Oral, once daily, 2 weeks

Primary outcomes

  1. 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

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

    Time frame: throughout the study

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Dose-Ranging Study of the Pharmacodynamic Effects of BMS-562086 on Gastrointestinal Transit in Women With Diarrhea-Predominant Irritable Bowel Syndrome

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Nov 14, 2006
Registry last updated
Sep 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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