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NCT00441766 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain
A Phase 2 study, sponsored by Allergan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 213
- Enrollment target
NCT00441766: Clinical Trial Phase 2 study, sponsored by Allergan.
NCT00441766 is a Phase 2 study that was terminated before completion, run by Allergan. The registered enrollment target is 213 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00441766, a Phase 2 study, was terminated before completion, sponsored by Allergan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 213 participants
- Enrollment target
Study Summary
This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.
Primary Outcome
Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).
Interventions
- DRUG placebo
- DRUG AGN 203818
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-02 |
| Phase | Phase 2 |
Why NCT00441766 stopped before completion
NCT00441766 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00441766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00441766 about?
NCT00441766 is a clinical study titled "Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain". This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 3...
What is the current status of trial NCT00441766?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 213 participants. The study started on 2007-03. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00441766?
The interventions under investigation include: placebo (DRUG), AGN 203818 (DRUG).
Who is sponsoring clinical trial NCT00441766?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00441766's enrollment target sits among peer trials
213 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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