NCT00399438

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

10 months

First QC Date

November 13, 2006

Last Update Submit

September 25, 2008

Conditions

Irritable Bowel Syndrome

Keywords

Diarrhea-predominant irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

1

OTHER

0 mg

Drug: Placebo

2

OTHER

25 mg

Drug: BMS-562086

3

OTHER

100 mg

Drug: BMS-562086

Interventions

PlaceboDRUG

Tablets, Oral, once daily, 2 weeks

1
BMS-562086DRUG

Tablets, Oral, once daily, 2 weeks

23

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire

You may not qualify if:

  • Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

pexacerfont

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

December 1, 2006

Primary Completion

October 1, 2007

Study Completion

January 1, 2008

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

US(1)