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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85013 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia, Sleep Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00883740
Pfizer
Completed
Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

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Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
Effects Of Pregabalin On Sleep Maintenance In Subjects With Fibromyalgia Syndrome And Sleep Maintenance Disturbance: A Randomized Placebo-Controlled 2-Way Crossover Polysomnography Study
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)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Fibromyalgia
  • Sleep Disorders
  • Drug: Pregabalin
    Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day
  • Drug: Placebo
    Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks
  • Experimental: Lyrica
    flexible dosing Lyrica 300-450mg/day
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Roth T, Lankford DA, Bhadra P, Whalen E, Resnick EM. Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study. Arthritis Care Res (Hoboken). 2012 Apr;64(4):597-606. doi: 10.1002/acr.21595.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
June 2010
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   United States
 
 
NCT00883740
A0081165
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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