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NCT00445705 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
A Phase 2 study, sponsored by Allergan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 211
- Enrollment target
NCT00445705: Clinical Trial Phase 2 study, sponsored by Allergan.
NCT00445705 is a Phase 2 study that was terminated before completion, run by Allergan. The registered enrollment target is 211 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00445705, a Phase 2 study, was terminated before completion, sponsored by Allergan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 211 participants
- Enrollment target
Study Summary
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.
Primary Outcome
Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. 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 | 211 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
Why NCT00445705 stopped before completion
NCT00445705 is an interventional study that assigns participants to a tested intervention. The registered 211 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 (59% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00445705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00445705 about?
NCT00445705 is a clinical study titled "Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome". This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. ...
What is the current status of trial NCT00445705?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 211 participants. The study started on 2007-03. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00445705?
The interventions under investigation include: placebo (DRUG), AGN 203818 (DRUG).
Who is sponsoring clinical trial NCT00445705?
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 NCT00445705's enrollment target sits among peer trials
211 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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