Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00067457
First received: August 20, 2003
Last updated: May 31, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Colon Irritable Bowel Syndrome (IBS) |
Drug: alosetron |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
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 ]
| Enrollment: | 702 |
| Study Start Date: | June 2003 |
Intervention Details:
-
Drug: alosetron
Other Name: alosetron
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067457
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| United States, Alabama | |
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| Birmingham, Alabama, United States, 35235 | |
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| Australia, Western Australia | |
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| Nedlands, Western Australia, Australia, 27408 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00067457 History of Changes |
| Other Study ID Numbers: | S3B30048 |
| Study First Received: | August 20, 2003 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
PRN Diarrhea-Predominant Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) |
Additional relevant MeSH terms:
|
Diarrhea Irritable Bowel Syndrome Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Alosetron Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013