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

21. januar 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

751

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Pfizer Investigational Site
      • Huntsville, Alabama, Forenede Stater, 35801
        • Pfizer Investigational Site
    • Arizona
      • Paradise Valley, Arizona, Forenede Stater, 85253
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85032
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85023
        • Pfizer Investigational Site
      • Scottsdale, Arizona, Forenede Stater, 85254
        • Pfizer Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • Pfizer Investigational Site
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Pfizer Investigational Site
      • Long Beach, California, Forenede Stater, 90806
        • Pfizer Investigational Site
      • Los Alamitos, California, Forenede Stater, 90720
        • Pfizer Investigational Site
      • Newport Beach, California, Forenede Stater, 92660
        • Pfizer Investigational Site
      • Northridge, California, Forenede Stater, 91324-4625
        • Pfizer Investigational Site
      • Northridge, California, Forenede Stater, 91335
        • Pfizer Investigational Site
      • Pismo Beach, California, Forenede Stater, 93449
        • Pfizer Investigational Site
      • Redondo Beach, California, Forenede Stater, 90277
        • Pfizer Investigational Site
      • Riverside, California, Forenede Stater, 92506
        • Pfizer Investigational Site
      • Riverside, California, Forenede Stater, 92501
        • Pfizer Investigational Site
      • Walnut Creek, California, Forenede Stater, 94598
        • Pfizer Investigational Site
      • Whittier, California, Forenede Stater, 90601
        • Pfizer Investigational Site
    • Connecticut
      • Danbury, Connecticut, Forenede Stater, 06810
        • Pfizer Investigational Site
      • New Milford, Connecticut, Forenede Stater, 06776
        • Pfizer Investigational Site
      • Stratford, Connecticut, Forenede Stater, 06615
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, Forenede Stater, 33761
        • Pfizer Investigational Site
      • Miami, Florida, Forenede Stater, 33173
        • Pfizer Investigational Site
      • Ocala, Florida, Forenede Stater, 34474
        • Pfizer Investigational Site
      • Palm Beach Gardens, Florida, Forenede Stater, 33410
        • Pfizer Investigational Site
      • Plantation, Florida, Forenede Stater, 33324
        • Pfizer Investigational Site
      • Plantation, Florida, Forenede Stater, 33317
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, Forenede Stater, 33710
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, Forenede Stater, 33709
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, Forenede Stater, 33703
        • Pfizer Investigational Site
      • Sunrise, Florida, Forenede Stater, 33351-6637
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33409
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, Forenede Stater, 30328
        • Pfizer Investigational Site
      • Decatur, Georgia, Forenede Stater, 30033-5930
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, Forenede Stater, 83704
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60610
        • Pfizer Investigational Site
      • Maywood, Illinois, Forenede Stater, 60153
        • Pfizer Investigational Site
      • Oak Brook, Illinois, Forenede Stater, 60523
        • Pfizer Investigational Site
      • Peoria, Illinois, Forenede Stater, 61614
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Pfizer Investigational Site
      • Overland Park, Kansas, Forenede Stater, 66215
        • Pfizer Investigational Site
      • Overland Park, Kansas, Forenede Stater, 66210
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70114
        • Pfizer Investigational Site
    • Massachusetts
      • Newton, Massachusetts, Forenede Stater, 02462
        • Pfizer Investigational Site
    • Michigan
      • East Lansing, Michigan, Forenede Stater, 48823
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, Forenede Stater, 49009
        • Pfizer Investigational Site
      • Lansing, Michigan, Forenede Stater, 48917
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64114
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03766
        • Pfizer Investigational Site
    • New Jersey
      • Princeton, New Jersey, Forenede Stater, 08540
        • Pfizer Investigational Site
    • New York
      • Albany, New York, Forenede Stater, 12205
        • Pfizer Investigational Site
      • New York, New York, Forenede Stater, 10003
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28210
        • Pfizer Investigational Site
      • Wilmington, North Carolina, Forenede Stater, 28403
        • Pfizer Investigational Site
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Pfizer Investigational Site
      • Columbus, Ohio, Forenede Stater, 43212
        • Pfizer Investigational Site
      • Columbus, Ohio, Forenede Stater, 43124
        • Pfizer Investigational Site
      • Mogadore, Ohio, Forenede Stater, 44260
        • Pfizer Investigational Site
      • Toledo, Ohio, Forenede Stater, 43623
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73109
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
        • Pfizer Investigational Site
      • Medford, Oregon, Forenede Stater, 97504
        • Pfizer Investigational Site
      • Portland, Oregon, Forenede Stater, 97201
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • Pfizer Investigational Site
      • Altoona, Pennsylvania, Forenede Stater, 16601
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • Pfizer Investigational Site
      • Johnstown, Pennsylvania, Forenede Stater, 15904
        • Pfizer Investigational Site
      • Mechanicsburg, Pennsylvania, Forenede Stater, 17055
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19146
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19115
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15218
        • Pfizer Investigational Site
      • Pottstown, Pennsylvania, Forenede Stater, 19610
        • Pfizer Investigational Site
      • West Reading, Pennsylvania, Forenede Stater, 19611-1124
        • Pfizer Investigational Site
      • Wyomissing, Pennsylvania, Forenede Stater, 19610
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • Pfizer Investigational Site
      • Charleston, South Carolina, Forenede Stater, 29406
        • Pfizer Investigational Site
      • Greer, South Carolina, Forenede Stater, 29651
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Pfizer Investigational Site
      • Memphis, Tennessee, Forenede Stater, 38104
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37203
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • Pfizer Investigational Site
      • Lubbock, Texas, Forenede Stater, 79424
        • Pfizer Investigational Site
      • Richardson, Texas, Forenede Stater, 75080
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229-4540
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84102
        • Pfizer Investigational Site
    • Vermont
      • Woodstock, Vermont, Forenede Stater, 05091
        • Pfizer Investigational Site
      • Woodstock, Vermont, Forenede Stater, 05091-0437
        • Pfizer Investigational Site
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23454
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Pfizer Investigational Site
      • Seattle, Washington, Forenede Stater, 98122
        • Pfizer Investigational Site
      • Yakima, Washington, Forenede Stater, 98902
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: EN
Medicin: Pregabalin
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Medicin: Pregabalin
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Medicin: Pregabalin
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Eksperimentel: B
Medicin: Pregabalin
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Medicin: Pregabalin
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Medicin: Pregabalin
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Eksperimentel: C
Medicin: Pregabalin
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Medicin: Pregabalin
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Medicin: Pregabalin
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Placebo komparator: D
Medicin: Placebo
Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in FIQ scores at Weeks 5, 9, and 13
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Weeks 5, 9, and 13
Baseline and Weeks 5, 9, and 13
Quality of Sleep Score from the Daily Sleep Diary
Tidsramme: Daily
Daily
Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Weeks 9 and 13
Baseline and Weeks 9 and 13
Adverse events
Tidsramme: 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
Tidsramme: Baseline and Week 5 (vital signs only) and 13
Baseline and Week 5 (vital signs only) and 13
Neurological examination
Tidsramme: Screening and Week 13
Screening and Week 13
Electrocardiogram
Tidsramme: Screening and Week 13
Screening and Week 13
Laboratory tests, including chemistry and hematology
Tidsramme: Baseline and Weeks 5, 13, and at follow-up
Baseline and Weeks 5, 13, and at follow-up
Urinalysis
Tidsramme: Baseline and Weeks 13 and at follow-up
Baseline and Weeks 13 and at follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2004

Studieafslutning (Faktiske)

1. juni 2005

Datoer for studieregistrering

Først indsendt

25. marts 2008

Først indsendt, der opfyldte QC-kriterier

25. marts 2008

Først opslået (Skøn)

27. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. januar 2021

Sidst verificeret

1. april 2008

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A0081056

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pregabalin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Saudi Arabia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner