Status:
COMPLETED
Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Fibromyalgia
Sleep Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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)
Eligibility Criteria
Inclusion
- Subjects must meet diagnostic criteria for fibromyalgia;
- Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.
Exclusion
- History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;
- Use of medications known to affect sleep wake function by Visit 2;
- Involved in night or rotating shift work, or travel across \>4 time zones 14 days prior to screening and during study; regular daytime napping
- PSG finding of apnea/hypopnea or periodic limb movement with arousal index \>10/hr on either night of PSG.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00883740
Start Date
June 1 2009
End Date
June 1 2010
Last Update
January 25 2021
Active Locations (50)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85020
3
Pfizer Investigational Site
Tucson, Arizona, United States, 85741
4
Pfizer Investigational Site
San Diego, California, United States, 92102