A Safety Study Of Pregabalin In Fibromyalgia

Viatris

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282997

A0081078

Details and patient eligibility

About

To evaluate the safety of pregabalin in 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 complete the double-blind study.

Exclusion criteria

• Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)