Last updated: 11/04/2018 11:01:57

Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

GSK study ID
S3B30040
See study documents
Clinicaltrials.gov ID
NCT00067561
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects with Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy
Trial description: The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Alosetron
    • Enrollment:
    702
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Irritable Colon
    Product
    alosetron
    Collaborators
    Not applicable
    Study date(s)
    June 2003 to June 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
    • Failed conventional therapy.
    • Willing to make daily calls on a touch-tone telephone. Exclusion criteria:
    • History of or current chronic or severe constipation.
    • Bloody diarrhea, abdominal pain with rectal bleeding.
    • Thrombophlebitis.
    • Abnormal thyroid stimulating hormone (TSH) value.
    • Alcohol and/or substance abuse within past two years.
    • Pregnant or lactating.
    • History/treatment of malignancy within past five years.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bismarck, North Dakota, United States, 58501
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Farmington, New Mexico, United States, 87401
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bayshore, New York, United States, 11706
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44113
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    New Port Richey, Florida, United States, 34652
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bowling Green, Kentucky, United States, 42101
    Status
    Study Complete
    Contact us
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    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-01-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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