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A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

NCT00645398 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 751

Last updated 2021-01-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.

Conditions

  • Fibromyalgia

Interventions

DRUG

Pregabalin

Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

DRUG

Pregabalin

Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

DRUG

Pregabalin

Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

DRUG

Placebo

Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2005-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00645398 on ClinicalTrials.gov