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

21. januar 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

751

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: EN
Legemiddel: Pregabalin
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Legemiddel: Pregabalin
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Legemiddel: Pregabalin
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Eksperimentell: B
Legemiddel: Pregabalin
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Legemiddel: Pregabalin
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Legemiddel: Pregabalin
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Eksperimentell: C
Legemiddel: Pregabalin
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Legemiddel: Pregabalin
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Legemiddel: 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
Legemiddel: Placebo
Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2004

Studiet fullført (Faktiske)

1. juni 2005

Datoer for studieregistrering

Først innsendt

25. mars 2008

Først innsendt som oppfylte QC-kriteriene

25. mars 2008

Først lagt ut (Anslag)

27. mars 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. januar 2021

Sist bekreftet

1. april 2008

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A0081056

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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