A Study For Pregabalin In Patients With Fibromyalgia

Viatris

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: pregabalin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01387607

A0081241

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.

Enrollment: 343 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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343 participants in 2 patient groups, including a placebo group

Pregabalin

Experimental group

Treatment:

Drug: pregabalin

Placebo

Placebo Comparator group

Description:

Matched placebo

Treatment:

Drug: placebo