A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

Viatris

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645398

A0081056

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.

Enrollment: 751 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
• Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion criteria

• Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
• Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
• Patients with severe depression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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751 participants in 4 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

B

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

C

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

D

Placebo Comparator group

Treatment:

Drug: Placebo