Effects of Pregabalin (Lyrica) on Sleep Maintenance in Subjects With Fibromyalgia - NCT00883740-29201 (Clinical Trial 396013)


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Effects of Pregabalin (Lyrica) on Sleep Maintenance in Subjects With Fibromyalgia - NCT00883740-29201 (Clinical Trial 396013)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy396013.aspx

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City:

Columbia

State:

Zip Code:

29201

Conditions:

Fibromyalgia - Sleep Disorders

Purpose:

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)

Study summary:

Criteria:

Inclusion Criteria: - 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 Criteria: - 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.

Study is available at:

Pfizer Investigational Site
Columbia, SC 29201
United States

Primary Contact:
Pfizer CT.gov Call Center
Phone: 1-800-718-1021

If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.

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Data Source:		ClinicalTrials.gov
Date Processed:		March 16, 2010
Modifications to this listing:		Only selected fields are shown, please use the link above to view all information about this clinical trial.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.


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