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

Viatris

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00830167

A0081208

Details and patient eligibility

About

This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.

Enrollment: 498 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 VAS
• 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
• Patients with suicidality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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498 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Pregabalin

Experimental group

Treatment:

Drug: Pregabalin