A Controlled Pregabalin Trial In Fibromyalgia

Viatris

Status and phase

Completed

Phase 3

Conditions

Fibromyalgia

Treatments

Drug: placebo

Drug: pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00230776

A0081077

Details and patient eligibility

About

To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must meet the 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 must have a score of >40 mm on the Visual Analog Scale

Exclusion criteria

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