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NCT00067561 · ClinicalTrials.gov registry record · Phase 3
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
A Phase 3 study of Irritable Bowel Syndrome (IBS) and Irritable Colon, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 702
- Enrollment target
- 20
- Study locations
NCT00067561: Completed Phase 3 study of Irritable Bowel Syndrome (IBS) and Irritable Colon, sponsored by GlaxoSmithKline.
NCT00067561 is a Phase 3 study of Irritable Bowel Syndrome (IBS) and Irritable Colon that has completed, run by GlaxoSmithKline. The registered enrollment target is 702 participants, below the 1,048-participant average among 5 other Irritable Bowel Syndrome (IBS) trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00067561, a Phase 3 study of Irritable Bowel Syndrome (IBS) and Irritable Colon, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 702 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Alosetron
Study Locations (20)
California
- GSK Investigational Site - Chula Vista
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Garden Grove
- GSK Investigational Site - Lancaster
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Newport Beach
- GSK Investigational Site - Rancho Cucamonga
- GSK Investigational Site - Redlands
- GSK Investigational Site - San Diego
- GSK Investigational Site - San Diego
- GSK Investigational Site - San Rafael
- GSK Investigational Site - Santa Ana
- GSK Investigational Site - Santa Ana
- GSK Investigational Site - Upland
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Calera
- GSK Investigational Site - Tuscaloosa
Arizona
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tucson
Arkansas
- GSK Investigational Site - Fayetteville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 702 participants |
| Start Date | 2003-06 |
| Est. Completion | 2005-01 |
| Phase | Phase 3 |
What the finished NCT00067561 record still lists
NCT00067561 is an interventional study that assigns participants to a tested intervention. The registered 702 participants enrollment target is mid-sized for trials with a published cap, below the 1,048-participant average among 5 other Irritable Bowel Syndrome (IBS) trials with a reported enrollment target (33% lower).
The record links to 2 conditions, with Irritable Bowel Syndrome (IBS) appearing as the primary indexed condition, and to 1 intervention - of which Alosetron is the first listed.
NCT00067561 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00067561 about?
NCT00067561 is a clinical study titled "Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy". 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.
What is the current status of trial NCT00067561?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 702 participants. The study started on 2003-06. Estimated completion is 2005-01.
What conditions does trial NCT00067561 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome (IBS), Irritable Colon.
What interventions are being tested in trial NCT00067561?
The interventions under investigation include: Alosetron (DRUG).
Who is sponsoring clinical trial NCT00067561?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00067561 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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