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

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
751

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
      • Scottsdale, Arizona, United States, 85254
        • Pfizer Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, United States, 90211
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
      • Los Alamitos, California, United States, 90720
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660
        • Pfizer Investigational Site
      • Northridge, California, United States, 91324-4625
        • Pfizer Investigational Site
      • Northridge, California, United States, 91335
        • Pfizer Investigational Site
      • Pismo Beach, California, United States, 93449
        • Pfizer Investigational Site
      • Redondo Beach, California, United States, 90277
        • Pfizer Investigational Site
      • Riverside, California, United States, 92506
        • Pfizer Investigational Site
      • Riverside, California, United States, 92501
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598
        • Pfizer Investigational Site
      • Whittier, California, United States, 90601
        • Pfizer Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Pfizer Investigational Site
      • New Milford, Connecticut, United States, 06776
        • Pfizer Investigational Site
      • Stratford, Connecticut, United States, 06615
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33173
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
      • Palm Beach Gardens, Florida, United States, 33410
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33317
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, United States, 33710
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, United States, 33709
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, United States, 33703
        • Pfizer Investigational Site
      • Sunrise, Florida, United States, 33351-6637
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30328
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033-5930
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Pfizer Investigational Site
      • Maywood, Illinois, United States, 60153
        • Pfizer Investigational Site
      • Oak Brook, Illinois, United States, 60523
        • Pfizer Investigational Site
      • Peoria, Illinois, United States, 61614
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66215
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66210
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70114
        • Pfizer Investigational Site
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • Pfizer Investigational Site
    • Michigan
      • East Lansing, Michigan, United States, 48823
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, United States, 49009
        • Pfizer Investigational Site
      • Lansing, Michigan, United States, 48917
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Pfizer Investigational Site
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • Pfizer Investigational Site
      • New York, New York, United States, 10003
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • Wilmington, North Carolina, United States, 28403
        • Pfizer Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • 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
      • Columbus, Ohio, United States, 43124
        • Pfizer Investigational Site
      • Mogadore, Ohio, United States, 44260
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43623
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97201
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Pfizer Investigational Site
      • Altoona, Pennsylvania, United States, 16601
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
      • Johnstown, Pennsylvania, United States, 15904
        • Pfizer Investigational Site
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19146
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19115
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15218
        • Pfizer Investigational Site
      • Pottstown, Pennsylvania, United States, 19610
        • Pfizer Investigational Site
      • West Reading, Pennsylvania, United States, 19611-1124
        • Pfizer Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Pfizer Investigational Site
      • Charleston, South Carolina, United States, 29406
        • Pfizer Investigational Site
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38104
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Lubbock, Texas, United States, 79424
        • Pfizer Investigational Site
      • Richardson, Texas, United States, 75080
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229-4540
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Pfizer Investigational Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Pfizer Investigational Site
      • Woodstock, Vermont, United States, 05091-0437
        • Pfizer Investigational Site
    • Virginia
      • 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
      • Yakima, Washington, United States, 98902
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who met the American College of Rheumatology (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 who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion Criteria:

  • Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
  • Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
  • Patients with severe depression

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
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).
Experimental: B
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).
Experimental: C
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).
Placebo Comparator: D
Drug: Placebo
Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Endpoint mean pain score derived from the subject's daily pain diary
Time Frame: Endpoint
Endpoint
Patient Global Assessment (Patient Global Impression of Change) at Termination Visit
Time Frame: Weeks 5 and 13
Weeks 5 and 13
Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit
Time Frame: Baseline and Weeks 5, 9, and 13
Baseline and Weeks 5, 9, and 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in FIQ scores at Weeks 5, 9, and 13
Time Frame: Baseline and Weeks 5, 9, and 13
Baseline and Weeks 5, 9, and 13
Change from baseline in SDS scores at Weeks 5, 9, and 13
Time Frame: Baseline and Weeks 5, 9, and 13
Baseline and Weeks 5, 9, and 13
Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale scores at Weeks 5, 9, and 13
Time Frame: Baseline and Weeks 5, 9, and 13
Baseline and Weeks 5, 9, and 13
Quality of Sleep Score from the Daily Sleep Diary
Time Frame: Daily
Daily
Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13
Time Frame: Baseline and Weeks 5, 9, and 13
Baseline and Weeks 5, 9, and 13
Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13
Time Frame: Baseline and Week 13
Baseline and Week 13
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at Weeks 5, 9, and 13
Time Frame: Screening, baseline, and Weeks 5, 9, and 13
Screening, baseline, and Weeks 5, 9, and 13
Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13
Time Frame: Baseline and Weeks 9 and 13
Baseline and Weeks 9 and 13
Adverse events
Time Frame: Weeks 1, 2, 5, 9, 13, and at follow-up
Weeks 1, 2, 5, 9, 13, and at follow-up
Physical examination, including vital signs and weight
Time Frame: Baseline and Week 5 (vital signs only) and 13
Baseline and Week 5 (vital signs only) and 13
Neurological examination
Time Frame: Screening and Week 13
Screening and Week 13
Electrocardiogram
Time Frame: Screening and Week 13
Screening and Week 13
Laboratory tests, including chemistry and hematology
Time Frame: Baseline and Weeks 5, 13, and at follow-up
Baseline and Weeks 5, 13, and at follow-up
Urinalysis
Time Frame: Baseline and Weeks 13 and at follow-up
Baseline and Weeks 13 and at follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A0081056

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.

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