Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
This study has been completed.
Information provided by (Responsible Party):
First received: August 20, 2003
Last updated: April 15, 2015
Last verified: April 2015
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.
Irritable Bowel Syndrome (IBS)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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. [ Time Frame: 12 Weeks ]
Secondary Outcome Measures:
- 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. [ Time Frame: 12 Weeks ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2005 (Final data collection date for primary outcome measure)
Other Name: alosetron
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
- Failed conventional therapy.
- Willing to make daily calls on a touch-tone telephone.
- History of or current chronic or severe constipation.
- Bloody diarrhea, abdominal pain with rectal bleeding.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00067457
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 20, 2003
||April 15, 2015
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Diarrhea-Predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 07, 2015
Irritable Bowel Syndrome
Colonic Diseases, Functional
Digestive System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs