Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

Viatris

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: placebo; Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01271933

A0081245

FIBROMYALGIA (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.

Enrollment: 441 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have fibromyalgia.

Exclusion criteria

• Patients with other painful conditions cannot participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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441 participants in 2 patient groups, including a placebo group

Pregabalin

Experimental group

Treatment:

Drug: pregabalin

Placebo

Placebo Comparator group

Treatment:

Drug: placebo