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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014