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A Study For Pregabalin In Patients With Fibromyalgia

Last updated on March 14, 2019

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Study Location
Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000 China
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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- Male or female patients, at least 18 years of age

- Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie,
widespread pain present for at least 3 months, and pain in at least 11 of 18 specific
tender point sites)

- At screening (V1) and randomization (V2), patients must have a score of no less than
40 mm on the Pain Visual Analog Scale (VAS)

- At randomization (V2), at least 4 pain diaries must be completed satisfactorily within
the last 7 days and the average pain score must be no less than 4

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at
randomization (V2) as compared to screening (V1)

- Patients with other severe pain due to other conditions (eg, DPN or PHN) that may
confound assessment or self-evaluation of the pain associated with fibromyalgia

- Patients with any widespread inflammatory musculoskeletal disorders, widespread
rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine
disorders

- CLcr less than 60 mL/min (estimated from serum creatinine)

NCT01387607
Pfizer
Completed
A Study For Pregabalin In Patients With Fibromyalgia

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