Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

Completed · Phase 3 · Has a placebo group

Conditions studied: Fibromyalgia, Sleep Disorders

In brief

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)

Key facts

Study ID

NCT00883740

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

119

Starts

2009-06-01

Expected to finish

2010-06-01

Last updated by the study team

2021-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Colorado Springs, Colorado, United States
• Pfizer Investigational Site — DeLand, Florida, United States
• Pfizer Investigational Site — Hallandale, Florida, United States
• Pfizer Investigational Site — Orange City, Florida, United States
• Pfizer Investigational Site — Pembroke Pines, Florida, United States
• Pfizer Investigational Site — South Miami, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Crestview Hills, Kentucky, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Baton Rouge, Louisiana, United States
• Pfizer Investigational Site — Hattiesburg, Mississippi, United States
• Pfizer Investigational Site — Hattiesburg, Mississippi, United States
• Pfizer Investigational Site — Raleigh, North Carolina, United States
• Pfizer Investigational Site — Beachwood, Ohio, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Oklahoma City, Oklahoma, United States
• Pfizer Investigational Site — Oklahoma City, Oklahoma, United States
• Pfizer Investigational Site — Duncansville, Pennsylvania, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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