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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00067561 |
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Date of registration:
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21/08/2003 |
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Primary sponsor: |
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Public title:
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Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
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Scientific title:
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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 |
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Date of first enrolment:
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June 2003 |
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Target sample size:
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700 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00067561 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Irritable Bowel Syndrome (IBS)
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Irritable Colon
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Intervention(s)
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Drug: Alosetron
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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