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Safety and Efficacy Study of Pregabalin in Fibromyalgia

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
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.
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- At screening (V1), patients must meet the American College of Rheumatology criteria
for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at
least 11 of 18 specific tender point sites

- At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm
on the Pain Visual Analog Scale

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Other severe pain or inflammatory muscle or rheumatologic disease other than
fibromyalgia, active infections or untreated endocrine disorders; or severe depression
and other serious hepatic, respiratory, hematologic or immunologic illness or active
malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C,
HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy,
narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease
unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic
Arthritis, Scleroderma)

- Previous participation in a clinical trial with pregabalin; currently receiving or
pending disability claims or workmans compensation or civil litigation, or used other
experimental medicines within 30 days of screening

- Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low
platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation
rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF
greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)

- Use of prohibited pain/sleep medications (including antidepressants, sedatives,
hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior
to study entry.

NCT00151489
Pfizer
Completed
Safety and Efficacy Study of Pregabalin in Fibromyalgia

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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