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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00399438
First received: November 13, 2006
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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)


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Placebo
Drug: BMS-562086
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Dose-Ranging Study of the Pharmacodynamic Effects of BMS-562086 on Gastrointestinal Transit in Women With Diarrhea-Predominant Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: December 2006
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
0 mg
Drug: Placebo
Tablets, Oral, once daily, 2 weeks
2
25 mg
Drug: BMS-562086
Tablets, Oral, once daily, 2 weeks
3
100 mg
Drug: BMS-562086
Tablets, Oral, once daily, 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399438

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00399438     History of Changes
Other Study ID Numbers: CN148-013
Study First Received: November 13, 2006
Last Updated: September 25, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Diarrhea-predominant irritable bowel syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014