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NCT00883740 · ClinicalTrials.gov registry record · Phase 3
Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
A Phase 3 study of Fibromyalgia and Sleep Disorders, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
- 20
- Study locations
NCT00883740: Completed Phase 3 study of Fibromyalgia and Sleep Disorders, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00883740 is a Phase 3 study of Fibromyalgia and Sleep Disorders that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 119 participants, below the 178-participant average among 76 other Fibromyalgia trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00883740, a Phase 3 study of Fibromyalgia and Sleep Disorders, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)
Primary Outcome
WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography \[PSG\]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording \[i.e. awake epoch immediately prior to the end of the recording\]) on 2 consecutive nights divided by 2 at the end of each intervention period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pregabalin
Study Locations (20)
Florida
- Pfizer Investigational Site - DeLand
- Pfizer Investigational Site - Hallandale
- Pfizer Investigational Site - Orange City
- Pfizer Investigational Site - Pembroke Pines
- Pfizer Investigational Site - South Miami
Arizona
- Pfizer Investigational Site - Phoenix
- Pfizer Investigational Site - Phoenix
- Pfizer Investigational Site - Tucson
Kentucky
- Pfizer Investigational Site - Crestview Hills
- Pfizer Investigational Site - Louisville
Mississippi
- Pfizer Investigational Site - Hattiesburg
- Pfizer Investigational Site - Hattiesburg
California
- Pfizer Investigational Site - San Diego
Colorado
- Pfizer Investigational Site - Colorado Springs
Georgia
- Pfizer Investigational Site - Atlanta
Illinois
- Pfizer Investigational Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2009-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00883740 record still lists
NCT00883740 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 178-participant average among 76 other Fibromyalgia trials with a reported enrollment target (33% lower).
The record links to 2 conditions, with Fibromyalgia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00883740 names 20 study sites across 12 states, led by Florida, Arizona, Kentucky.
Frequently Asked Questions
What is clinical trial NCT00883740 about?
NCT00883740 is a clinical study titled "Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia". The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)
What is the current status of trial NCT00883740?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2009-06. Estimated completion is 2010-06.
What conditions does trial NCT00883740 study?
This clinical trial studies the following conditions: Fibromyalgia, Sleep Disorders.
What interventions are being tested in trial NCT00883740?
The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG).
Who is sponsoring clinical trial NCT00883740?
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.
Where is trial NCT00883740 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fibromyalgia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00883740's enrollment target sits among peer trials
119 27th of 76 higher than 50 of 76 other Fibromyalgia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fibromyalgia 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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