A Controlled Pregabalin Trial In Fibromyalgia

January 22, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia

To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia

Study Overview

Status

Completed

Conditions

Fibromyalgia

Intervention / Treatment

Study Type

Interventional

Enrollment

740

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Pfizer Investigational Site
- California
  - Fresno, California, United States, 93710
    - Pfizer Investigational Site
  - La Jolla, California, United States, 92037
    - Pfizer Investigational Site
  - Northridge, California, United States, 91325
    - Pfizer Investigational Site
  - Pismo Beach, California, United States, 93449
    - Pfizer Investigational Site
  - Sacramento, California, United States, 95825
    - Pfizer Investigational Site
  - San Diego, California, United States, 92103
    - Pfizer Investigational Site
  - Walnut Creek, California, United States, 94598
    - Pfizer Investigational Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Pfizer Investigational Site
- Florida
  - DeLand, Florida, United States, 32720
    - Pfizer Investigational Site
  - Gainesville, Florida, United States, 32610-0221
    - Pfizer Investigational Site
  - Hollywood, Florida, United States, 33023
    - Pfizer Investigational Site
  - Melbourne, Florida, United States, 32901
    - Pfizer Investigational Site
  - Ocala, Florida, United States, 34471
    - Pfizer Investigational Site
  - Ocala, Florida, United States, 34474
    - Pfizer Investigational Site
  - Palm Beach Gardens, Florida, United States, 33410
    - Pfizer Investigational Site
  - Palm Harbor, Florida, United States, 34684
    - Pfizer Investigational Site
  - Sunrise, Florida, United States, 33351
    - Pfizer Investigational Site
  - Tampa, Florida, United States, 33614
    - Pfizer Investigational Site
  - Tampa, Florida, United States, 33606
    - Pfizer Investigational Site
  - West Palm Beach, Florida, United States, 33407
    - Pfizer Investigational Site
- Illinois
  - Gurnee, Illinois, United States, 60031
    - Pfizer Investigational Site
  - Moline, Illinois, United States, 61265
    - Pfizer Investigational Site
  - Morton Grove, Illinois, United States, 60053
    - Pfizer Investigational Site
- Indiana
  - Indianapolis, Indiana, United States, 46250
    - Pfizer Investigational Site
  - Indianapolis, Indiana, United States, 46202-5250
    - Pfizer Investigational Site
- Iowa
  - Dubuque, Iowa, United States, 52001
    - Pfizer Investigational Site
  - Dubuque, Iowa, United States, 52002
    - Pfizer Investigational Site
- Kansas
  - Prairie Village, Kansas, United States, 66206
    - Pfizer Investigational Site
  - Pratt, Kansas, United States, 67124
    - Pfizer Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - Pfizer Investigational Site
- Louisiana
  - Kenner, Louisiana, United States, 70065
    - Pfizer Investigational Site
  - Metairie, Louisiana, United States, 70006
    - Pfizer Investigational Site
- Massachusetts
  - North Dartmouth, Massachusetts, United States, 02747
    - Pfizer Investigational Site
  - Watertown, Massachusetts, United States, 02472
    - Pfizer Investigational Site
  - Worcester, Massachusetts, United States, 01610
    - Pfizer Investigational Site
- Michigan
  - Lansing, Michigan, United States, 48910
    - Pfizer Investigational Site
- Minnesota
  - Chaska, Minnesota, United States, 55318
    - Pfizer Investigational Site
  - Saint Paul, Minnesota, United States, 55101
    - Pfizer Investigational Site
- Missouri
  - Jefferson City, Missouri, United States, 65109
    - Pfizer Investigational Site
  - Kansas City, Missouri, United States, 64106
    - Pfizer Investigational Site
  - Saint Louis, Missouri, United States, 63141
    - Pfizer Investigational Site
- Nebraska
  - Lincoln, Nebraska, United States, 68516
    - Pfizer Investigational Site
- New Jersey
  - Morristown, New Jersey, United States, 07960
    - Pfizer Investigational Site
- New York
  - Albany, New York, United States, 12205
    - Pfizer Investigational Site
  - Endwell, New York, United States, 13760
    - Pfizer Investigational Site
  - New York, New York, United States, 10022-1009
    - Pfizer Investigational Site
  - West Seneca, New York, United States, 14224
    - Pfizer Investigational Site
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Pfizer Investigational Site
  - Hickory, North Carolina, United States, 28601
    - Pfizer Investigational Site
  - Hickory, North Carolina, United States, 28602
    - Pfizer Investigational Site
  - Raleigh, North Carolina, United States, 27609
    - Pfizer Investigational Site
  - Salisbury, North Carolina, United States, 28144
    - Pfizer Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - Pfizer Investigational Site
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Pfizer Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Pfizer Investigational Site
  - Cincinnati, Ohio, United States, 45227
    - Pfizer Investigational Site
  - Cincinnati, Ohio, United States, 45245
    - Pfizer Investigational Site
  - Dayton, Ohio, United States, 45402
    - Pfizer Investigational Site
  - Toledo, Ohio, United States, 43623
    - Pfizer Investigational Site
- Oklahoma
  - Tulsa, Oklahoma, United States, 74104-5428
    - Pfizer Investigational Site
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Pfizer Investigational Site
  - Bethlehem, Pennsylvania, United States, 18015
    - Pfizer Investigational Site
  - Norristown, Pennsylvania, United States, 19401
    - Pfizer Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Pfizer Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15218
    - Pfizer Investigational Site
- South Carolina
  - Goose Creek, South Carolina, United States, 29445
    - Pfizer Investigational Site
  - Mount Pleasant, South Carolina, United States, 29464
    - Pfizer Investigational Site
  - Myrtle Beach, South Carolina, United States, 29572
    - Pfizer Investigational Site
  - Summerville, South Carolina, United States, 29485
    - Pfizer Investigational Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Pfizer Investigational Site
  - Knoxville, Tennessee, United States, 37909-1900
    - Pfizer Investigational Site
  - Milan, Tennessee, United States, 38358
    - Pfizer Investigational Site
  - Nashville, Tennessee, United States, 37203
    - Pfizer Investigational Site
- Texas
  - Bedford, Texas, United States, 76021
    - Pfizer Investigational Site
  - Georgetown, Texas, United States, 78626
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77030
    - Pfizer Investigational Site
  - Killeen, Texas, United States, 76549
    - Pfizer Investigational Site
  - Lake Jackson, Texas, United States, 77566
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78229
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78213
    - Pfizer Investigational Site
- Utah
  - Salt Lake City, Utah, United States, 84102-1571
    - Pfizer Investigational Site
- Vermont
  - Woodstock, Vermont, United States, 05091
    - Pfizer Investigational Site
- Virginia
  - Virginia Beach, Virginia, United States, 23455
    - Pfizer Investigational Site
- Washington
  - Everett, Washington, United States, 98201
    - Pfizer Investigational Site
  - Spokane, Washington, United States, 99204
    - Pfizer Investigational Site
  - Spokane, Washington, United States, 99216
    - Pfizer Investigational Site
  - Tacoma, Washington, United States, 98405
    - Pfizer Investigational Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53209
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 have a score of >40 mm on the Visual Analog Scale

Exclusion Criteria:

Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Secondary Outcome Measures

Outcome Measure
To evaluate the efficacy of pregabalin for improvement in sleep, fatigue, health-related quality of life, functioning and mood disturbance associated with fibromyalgia. To evaluate safety and tolerability.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

October 3, 2005

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A0081077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.