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| Descriptive Information Fields | |||||
| Brief Title † | Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy | ||||
| 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 | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | 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 Measure † | 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 ] | ||||
| Condition † | Irritable Bowel Syndrome | ||||
| Intervention † | Drug: alosetron | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 702 | ||||
| Start Date † | June 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00067457 | ||||
| Organization ID | S3B30048 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | GlaxoSmithKline | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | September 2007 | ||||
| First Received Date † | August 20, 2003 | ||||
| Last Updated Date | September 24, 2007 | ||||