Last updated: 11/04/2018 11:02:10

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

GSK study ID
S3B30048
See study documents
Clinicaltrials.gov ID
NCT00067457
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 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects with Severe Diarrhea-Predominant Irritable Bowel Syndrome Who Have Failed Conventional Therapy
Trial description: The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for 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:

Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.

Timeframe: 12 Weeks

Secondary outcomes:

Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.

Timeframe: 12 Weeks

Interventions:
  • Drug: alosetron
    • Enrollment:
    700
    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 December 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
    Norfolk, Virginia, United States, 23507
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45236
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Media, Pennsylvania, United States, 19063
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23294
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Brooklyn Center, Minnesota, United States, 55430
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85712
    Status
    Recruiting
    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
    2005-28-12

    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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