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NCT00645398 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 751
- Enrollment target
NCT00645398: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00645398 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 751 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00645398, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 751 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.
Interventions
- DRUG Placebo
- DRUG Pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 751 participants |
| Start Date | 2004-09 |
| Est. Completion | 2005-06 |
| Phase | Phase 3 |
What the finished NCT00645398 record still lists
NCT00645398 is an interventional study that assigns participants to a tested intervention. The registered 751 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00645398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00645398 about?
NCT00645398 is a clinical study titled "A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia". The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the manageme...
What is the current status of trial NCT00645398?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 751 participants. The study started on 2004-09. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00645398?
The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG).
Who is sponsoring clinical trial NCT00645398?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00645398's enrollment target sits among peer trials
751 462nd of 2000 higher than 1,537 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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