Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.

Viatris

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: placebo; Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333866

A0081100

Details and patient eligibility

About

This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.

Enrollment: 747 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ACR criteria for fibromyalgia
• A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries

Exclusion criteria

• Patients with other severe pain conditions
• Patients with severe depression
• Patients taking excluded medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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747 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

2

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

3

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

4

Placebo Comparator group

Treatment:

Drug: placebo