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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645398
First received: March 25, 2008
Last updated: April 23, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Pregabalin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 13-Week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint mean pain score derived from the subject's daily pain diary [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Patient Global Assessment (Patient Global Impression of Change) at Termination Visit [ Time Frame: Weeks 5 and 13 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in FIQ scores at Weeks 5, 9, and 13 [ Time Frame: Baseline and Weeks 5, 9, and 13 ] [ Designated as safety issue: No ]
  • Change from baseline in SDS scores at Weeks 5, 9, and 13 [ Time Frame: Baseline and Weeks 5, 9, and 13 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of Sleep Score from the Daily Sleep Diary [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13 [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13 [ Time Frame: Baseline and Weeks 9 and 13 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Weeks 1, 2, 5, 9, 13, and at follow-up ] [ Designated as safety issue: Yes ]
  • Physical examination, including vital signs and weight [ Time Frame: Baseline and Week 5 (vital signs only) and 13 ] [ Designated as safety issue: Yes ]
  • Neurological examination [ Time Frame: Screening and Week 13 ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: Screening and Week 13 ] [ Designated as safety issue: Yes ]
  • Laboratory tests, including chemistry and hematology [ Time Frame: Baseline and Weeks 5, 13, and at follow-up ] [ Designated as safety issue: Yes ]
  • Urinalysis [ Time Frame: Baseline and Weeks 13 and at follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 751
Study Start Date: September 2004
Study Completion Date: June 2005
Arms Assigned Interventions
Experimental: A Drug: Pregabalin
Pregabalin 150 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).
Experimental: C 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645398

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Pfizer Investigational Site
Paradise Valley, Arizona, United States, 85253
Pfizer Investigational Site
Phoenix, Arizona, United States, 85032
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Phoenix, Arizona, United States, 85023
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Scottsdale, Arizona, United States, 85254
United States, Arkansas
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
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Long Beach, California, United States, 90806
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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
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Riverside, California, United States, 92501
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Riverside, California, United States, 92506
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Walnut Creek, California, United States, 94598
Pfizer Investigational Site
Whittier, California, United States, 90601
United States, Connecticut
Pfizer Investigational Site
Danbury, Connecticut, United States, 06810
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New Milford, Connecticut, United States, 06776
Pfizer Investigational Site
Stratford, Connecticut, United States, 06615
United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33761
Pfizer Investigational Site
Miami, Florida, United States, 33173
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Ocala, Florida, United States, 34474
Pfizer Investigational Site
Palm Beach Gardens, Florida, United States, 33410
Pfizer Investigational Site
Plantation, Florida, United States, 33317
Pfizer Investigational Site
Plantation, Florida, United States, 33324
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St. Petersburg, Florida, United States, 33709
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33703
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33710
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Sunrise, Florida, United States, 33351-6637
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West Palm Beach, Florida, United States, 33409
United States, Georgia
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Atlanta, Georgia, United States, 30328
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Atlanta, Georgia, United States, 30342
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Decatur, Georgia, United States, 30033-5930
United States, Idaho
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Boise, Idaho, United States, 83704
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
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Maywood, Illinois, United States, 60153
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Oak Brook, Illinois, United States, 60523
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Peoria, Illinois, United States, 61614
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66160
Pfizer Investigational Site
Overland Park, Kansas, United States, 66215
Pfizer Investigational Site
Overland Park, Kansas, United States, 66210
United States, Kentucky
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Madisonville, Kentucky, United States, 42431
United States, Louisiana
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New Orleans, Louisiana, United States, 70114
United States, Massachusetts
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Newton, Massachusetts, United States, 02462
United States, Michigan
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East Lansing, Michigan, United States, 48823
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49009
Pfizer Investigational Site
Lansing, Michigan, United States, 48917
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64114
United States, New Hampshire
Pfizer Investigational Site
Lebanon, New Hampshire, United States, 03766
United States, New Jersey
Pfizer Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
Pfizer Investigational Site
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
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
Wilmington, North Carolina, United States, 28401
Pfizer Investigational Site
Wilmington, North Carolina, United States, 28403
Pfizer Investigational Site
Winston Salem, North Carolina, United States, 27103
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Columbus, Ohio, United States, 43212
Pfizer Investigational Site
Columbus, Ohio, United States, 43124
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Mogadore, Ohio, United States, 44260
Pfizer Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73109
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
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Medford, Oregon, United States, 97504
Pfizer Investigational Site
Portland, Oregon, United States, 97201
United States, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16601
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16602
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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
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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
United States, South Carolina
Pfizer Investigational Site
Anderson, South Carolina, United States, 29621
Pfizer Investigational Site
Charleston, South Carolina, United States, 29406
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
Pfizer Investigational Site
Memphis, Tennessee, United States, 38104
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
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, 78229-4540
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
United States, Vermont
Pfizer Investigational Site
Woodstock, Vermont, United States, 05091
Pfizer Investigational Site
Woodstock, Vermont, United States, 05091-0437
United States, Virginia
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23454
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Pfizer Investigational Site
Seattle, Washington, United States, 98122
Pfizer Investigational Site
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645398     History of Changes
Other Study ID Numbers: A0081056
Study First Received: March 25, 2008
Last Updated: April 23, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014