Safety and Efficacy Study of Pregabalin in Fibromyalgia

January 20, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia

The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people.

Study Overview

Status

Completed

Conditions

Fibromyalgia

Intervention / Treatment

Study Type

Interventional

Enrollment

1020

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
- Alabama
  - Anniston, Alabama, United States, 36207
    - Pfizer Investigational Site
  - Birmingham, Alabama, United States, 35235
    - Pfizer Investigational Site
  - Calera, Alabama, United States, 35040
    - Pfizer Investigational Site
  - Huntsville, Alabama, United States, 35801
    - Pfizer Investigational Site
  - Tuscaloosa, Alabama, United States, 35406
    - Pfizer Investigational Site
- Arizona
  - Phoenix, Arizona, United States, 85023
    - Pfizer Investigational Site
  - Phoenix, Arizona, United States, 85013
    - Pfizer Investigational Site
  - Scottsdale, Arizona, United States, 85251
    - Pfizer Investigational Site
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Pfizer Investigational Site
  - Hot Springs, Arkansas, United States, 71913
    - Pfizer Investigational Site
- California
  - Anaheim, California, United States, 92801
    - Pfizer Investigational Site
  - Carmichael, California, United States, 95608
    - Pfizer Investigational Site
  - Fresno, California, United States, 93710
    - Pfizer Investigational Site
  - Los Alamitos, California, United States, 90720
    - Pfizer Investigational Site
  - Northridge, California, United States, 91324
    - Pfizer Investigational Site
  - Pismo Beach, California, United States, 93449
    - Pfizer Investigational Site
  - Santa Ana, California, United States, 92705
    - Pfizer Investigational Site
  - Walnut Creek, California, United States, 94598
    - Pfizer Investigational Site
  - Whittier, California, United States, 90601
    - Pfizer Investigational Site
- Colorado
  - Denver, Colorado, United States, 80218
    - Pfizer Investigational Site
- Connecticut
  - Stratford, Connecticut, United States, 06615
    - Pfizer Investigational Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Pfizer Investigational Site
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Pfizer Investigational Site
- Florida
  - Chiefland, Florida, United States, 32680
    - Pfizer Investigational Site
  - Clearwater, Florida, United States, 33761
    - Pfizer Investigational Site
  - Kissimmee, Florida, United States, 34741
    - Pfizer Investigational Site
  - Miami, Florida, United States, 33173
    - Pfizer Investigational Site
  - Ocala, Florida, United States, 34471
    - Pfizer Investigational Site
  - Ocala, Florida, United States, 34474
    - Pfizer Investigational Site
  - Palm Harbor, Florida, United States, 34684
    - Pfizer Investigational Site
  - Palm Springs, Florida, United States, 33461
    - Pfizer Investigational Site
  - Plantation, Florida, United States, 33324
    - Pfizer Investigational Site
  - Plantation, Florida, United States, 33317
    - Pfizer Investigational Site
  - Saint Petersburg, Florida, United States, 33709
    - Pfizer Investigational Site
  - Sunrise, Florida, United States, 33351
    - Pfizer Investigational Site
  - Tampa, Florida, United States, 33609
    - Pfizer Investigational Site
  - West Palm Beach, Florida, United States, 33409
    - Pfizer Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30328
    - Pfizer Investigational Site
- Illinois
  - Gurnee, Illinois, United States, 60031
    - Pfizer Investigational Site
  - Peoria, Illinois, United States, 61614
    - Pfizer Investigational Site
- Indiana
  - Evansville, Indiana, United States, 47714
    - Pfizer Investigational Site
  - Evansville, Indiana, United States, 47712
    - Pfizer Investigational Site
  - Indianapolis, Indiana, United States, 46254
    - Pfizer Investigational Site
- Kansas
  - Prairie Village, Kansas, United States, 66206
    - Pfizer Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - Pfizer Investigational Site
  - Lexington, Kentucky, United States, 40536
    - Pfizer Investigational Site
  - Lexington, Kentucky, United States, 40536-0284
    - Pfizer Investigational Site
  - Owensboro, Kentucky, United States, 42303
    - Pfizer Investigational Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Pfizer Investigational Site
  - New Orleans, Louisiana, United States, 70114
    - Pfizer Investigational Site
  - New Orleans, Louisiana, United States, 70128
    - Pfizer Investigational Site
- Massachusetts
  - Springfield, Massachusetts, United States, 01107
    - Pfizer Investigational Site
  - Worcester, Massachusetts, United States, 01610
    - Pfizer Investigational Site
- Michigan
  - Kalamazoo, Michigan, United States, 49009
    - Pfizer Investigational Site
  - Lansing, Michigan, United States, 48917
    - Pfizer Investigational Site
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Pfizer Investigational Site
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - Pfizer Investigational Site
- Missouri
  - Blue Springs, Missouri, United States, 64014
    - Pfizer Investigational Site
  - Springfield, Missouri, United States, 65807
    - Pfizer Investigational Site
- Nevada
  - Henderson, Nevada, United States, 89014
    - Pfizer Investigational Site
- New Jersey
  - Cherry Hill, New Jersey, United States, 08002
    - Pfizer Investigational Site
  - Edison, New Jersey, United States, 08817
    - Pfizer Investigational Site
  - Highland Park, New Jersey, United States, 08904
    - Pfizer Investigational Site
  - Ridgewood, New Jersey, United States, 07450
    - Pfizer Investigational Site
  - South Eddison, New Jersey, United States, 08817
    - Pfizer Investigational Site
- New York
  - Albany, New York, United States, 12205
    - Pfizer Investigational Site
  - Johnson City, New York, United States, 13790
    - Pfizer Investigational Site
  - Rochester, New York, United States, 14618
    - Pfizer Investigational Site
  - Smithtown, New York, United States, 11787-2817
    - Pfizer Investigational Site
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - Pfizer Investigational Site
  - Charlotte, North Carolina, United States, 28209
    - Pfizer Investigational Site
  - Raleigh, North Carolina, United States, 27612
    - 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
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Pfizer Investigational Site
  - Columbus, Ohio, United States, 43212
    - Pfizer Investigational Site
  - Mogadore, Ohio, United States, 44260
    - Pfizer Investigational Site
  - Toledo, Ohio, United States, 43623
    - Pfizer Investigational Site
- Oklahoma
  - Tulsa, Oklahoma, United States, 74104
    - Pfizer Investigational Site
- Oregon
  - Eugene, Oregon, United States, 97401
    - Pfizer Investigational Site
  - Medford, Oregon, United States, 97504
    - Pfizer Investigational Site
- Pennsylvania
  - Bensalem, Pennsylvania, United States, 19020
    - Pfizer Investigational Site
  - Mechanicsburg, Pennsylvania, United States, 17055
    - Pfizer Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Pfizer Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15218
    - Pfizer Investigational Site
  - West Reading, Pennsylvania, United States, 19611-1124
    - Pfizer Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29406
    - Pfizer Investigational Site
  - Greenville, South Carolina, United States, 29601
    - Pfizer Investigational Site
  - Greer, South Carolina, United States, 29651
    - Pfizer Investigational Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Pfizer Investigational Site
- Tennessee
  - Memphis, Tennessee, United States, 38119
    - Pfizer Investigational Site
  - Nashville, Tennessee, United States, 37207
    - Pfizer Investigational Site
- Texas
  - Austin, Texas, United States, 78705
    - Pfizer Investigational Site
  - Fort Worth, Texas, United States, 76107
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78229
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78217
    - Pfizer Investigational Site
- Utah
  - Layton, Utah, United States, 84041
    - Pfizer Investigational Site
  - Layton, Utah, United States, 841041
    - Pfizer Investigational Site
  - Salt Lake City, Utah, United States, 84107
    - Pfizer Investigational Site
  - South Jordan, Utah, United States, 84095
    - Pfizer Investigational Site
- Virginia
  - Virginia Beach, Virginia, United States, 23455
    - Pfizer Investigational Site
  - Virginia Beach, Virginia, United States, 23454
    - Pfizer Investigational Site
- Washington
  - Seattle, Washington, United States, 98104
    - Pfizer Investigational Site
  - Seattle, Washington, United States, 98122
    - Pfizer Investigational Site
  - Seattle, Washington, United States, 98166-2967
    - Pfizer Investigational Site
  - Spokane, Washington, United States, 99204
    - Pfizer Investigational Site
  - Yakima, Washington, United States, 98902
    - Pfizer Investigational Site
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - 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:

At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites
At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale

Exclusion Criteria:

Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma)
Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening
Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)
Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.

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 (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale

Secondary Outcome Measures

Outcome Measure
To evaluate the efficacy of pregabalin (BID) compared with placebo treatment to relieve pain and to improve global assessment, functional status, sleep and fatigue associated with fibromyalgia using questionnaires. To evaluate the longterm safety

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

Pauer L, Atkinson G, Murphy TK, Petersel D, Zeiher B. Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. Clin J Pain. 2012 Sep;28(7):609-14. doi: 10.1097/AJP.0b013e31823dd315.

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

April 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A0081059

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.