NCT00067561CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 702
- Locations
- 178
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
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.
Secondary Outcomes
- Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.
Investigators
Study Sites (178)
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