Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
Phase 3
Completed
- Conditions
- Irritable Bowel Syndrome (IBS)Irritable Colon
- Registration Number
- NCT00067457
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 700
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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. 12 Weeks
- Secondary Outcome Measures
Name Time Method 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. 12 Weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇦🇺Nedlands, Western Australia, Australia