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

NCT00645398 | Completed Phase 3 DMC

• 1 other identifier: A0081056
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 102

Brief Summary

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• 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

Study Arms (4)

A

EXPERIMENTAL

Drug: Pregabalin

B

EXPERIMENTAL

Drug: Pregabalin

C

EXPERIMENTAL

Drug: Pregabalin

D

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregabalin DRUG

Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

B

Placebo DRUG

Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (102)

Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

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Huntsville, Alabama, 35801, United States

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Paradise Valley, Arizona, 85253, United States

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Phoenix, Arizona, 85023, United States

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Phoenix, Arizona, 85032, United States

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Scottsdale, Arizona, 85254, United States

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Hot Springs, Arkansas, 71913, United States

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Little Rock, Arkansas, 72205, United States

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Beverly Hills, California, 90211, United States

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Long Beach, California, 90806, United States

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Los Alamitos, California, 90720, United States

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Newport Beach, California, 92660, United States

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Northridge, California, 91324-4625, United States

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Northridge, California, 91335, United States

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Pismo Beach, California, 93449, United States

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Redondo Beach, California, 90277, United States

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Riverside, California, 92501, United States

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Riverside, California, 92506, United States

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Walnut Creek, California, 94598, United States

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Whittier, California, 90601, United States

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Danbury, Connecticut, 06810, United States

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New Milford, Connecticut, 06776, United States

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Stratford, Connecticut, 06615, United States

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Clearwater, Florida, 33761, United States

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Miami, Florida, 33173, United States

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Ocala, Florida, 34474, United States

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Palm Beach Gardens, Florida, 33410, United States

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Plantation, Florida, 33317, United States

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Plantation, Florida, 33324, United States

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St. Petersburg, Florida, 33703, United States

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St. Petersburg, Florida, 33709, United States

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St. Petersburg, Florida, 33710, United States

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Sunrise, Florida, 33351-6637, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033-5930, United States

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Boise, Idaho, 83704, United States

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Chicago, Illinois, 60610, United States

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Maywood, Illinois, 60153, United States

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Oak Brook, Illinois, 60523, United States

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Peoria, Illinois, 61614, United States

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Kansas City, Kansas, 66160, United States

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Overland Park, Kansas, 66210, United States

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Overland Park, Kansas, 66215, United States

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Madisonville, Kentucky, 42431, United States

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New Orleans, Louisiana, 70114, United States

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Newton, Massachusetts, 02462, United States

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East Lansing, Michigan, 48823, United States

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Kalamazoo, Michigan, 49009, United States

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Lansing, Michigan, 48917, United States

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Kansas City, Missouri, 64114, United States

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Lebanon, New Hampshire, 03766, United States

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Princeton, New Jersey, 08540, United States

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Albany, New York, 12205, United States

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New York, New York, 10003, United States

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Rochester, New York, 14618, United States

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Charlotte, North Carolina, 28210, United States

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Wilmington, North Carolina, 28401, United States

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Wilmington, North Carolina, 28403, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45219, United States

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Columbus, Ohio, 43124, United States

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Columbus, Ohio, 43212, United States

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Mogadore, Ohio, 44260, United States

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Toledo, Ohio, 43623, United States

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Oklahoma City, Oklahoma, 73109, United States

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Eugene, Oregon, 97401, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97201, United States

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Altoona, Pennsylvania, 16601, United States

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Altoona, Pennsylvania, 16602, United States

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Duncansville, Pennsylvania, 16635, United States

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Johnstown, Pennsylvania, 15904, United States

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Mechanicsburg, Pennsylvania, 17055, United States

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Philadelphia, Pennsylvania, 19115, United States

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Philadelphia, Pennsylvania, 19146, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15218, United States

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Pittsburgh, Pennsylvania, 15224, United States

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Pottstown, Pennsylvania, 19610, United States

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West Reading, Pennsylvania, 19611-1124, United States

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Wyomissing, Pennsylvania, 19610, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29406, United States

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Greer, South Carolina, 29651, United States

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Memphis, Tennessee, 38104, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75246, United States

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Lubbock, Texas, 79424, United States

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Richardson, Texas, 75080, United States

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San Antonio, Texas, 78229-4540, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84102, United States

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Woodstock, Vermont, 05091-0437, United States

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Woodstock, Vermont, 05091, United States

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Virginia Beach, Virginia, 23454, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98122, United States

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Pfizer Investigational Site

Yakima, Washington, 98902, United States

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Related Publications (3)

• 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.

  PMID: 26694975 DERIVED

• 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.

  PMID: 21639874 DERIVED

• 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.

  PMID: 21039311 DERIVED

Related Links

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

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 27, 2008
• Study Start: September 1, 2004
• Study Completion: June 1, 2005
• Last Updated: January 25, 2021

Record last verified: 2008-04

Locations

US (102)