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

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: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Pregabalin; Drug: Pregabalin; Drug: Pregabalin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 751
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Endpoint mean pain score derived from the subject's daily pain diary	Endpoint
Patient Global Assessment (Patient Global Impression of Change) at Termination Visit	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	Baseline and Weeks 5, 9, and 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in FIQ scores at Weeks 5, 9, and 13	Baseline and Weeks 5, 9, and 13
Change from baseline in SDS scores at 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	Baseline and Weeks 5, 9, and 13
Quality of Sleep Score from the Daily Sleep Diary	Daily
Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at 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	Baseline and Week 13
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at 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	Baseline and Weeks 9 and 13
Adverse events	Weeks 1, 2, 5, 9, 13, and at follow-up
Physical examination, including vital signs and weight	Baseline and Week 5 (vital signs only) and 13
Neurological examination	Screening and Week 13
Electrocardiogram	Screening and Week 13
Laboratory tests, including chemistry and hematology	Baseline and Weeks 5, 13, and at follow-up
Urinalysis	Baseline and Weeks 13 and at follow-up

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.
• Straube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125. doi: 10.1186/1471-2474-12-125.
• Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. doi: 10.1517/14656566.2010.525217. Epub 2010 Nov 2.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: March 25, 2008
• First Submitted That Met QC Criteria: March 25, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081056