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Safety and Efficacy Study of Pregabalin in Fibromyalgia

20. januar 2021 opdateret af: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia

The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

1020

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
      • Anniston, Alabama, Forenede Stater, 36207
        • Pfizer Investigational Site
      • Birmingham, Alabama, Forenede Stater, 35235
        • Pfizer Investigational Site
      • Calera, Alabama, Forenede Stater, 35040
        • Pfizer Investigational Site
      • Huntsville, Alabama, Forenede Stater, 35801
        • Pfizer Investigational Site
      • Tuscaloosa, Alabama, Forenede Stater, 35406
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85023
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85013
        • Pfizer Investigational Site
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Pfizer Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, Forenede Stater, 72703
        • Pfizer Investigational Site
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • Pfizer Investigational Site
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Pfizer Investigational Site
      • Carmichael, California, Forenede Stater, 95608
        • Pfizer Investigational Site
      • Fresno, California, Forenede Stater, 93710
        • Pfizer Investigational Site
      • Los Alamitos, California, Forenede Stater, 90720
        • Pfizer Investigational Site
      • Northridge, California, Forenede Stater, 91324
        • Pfizer Investigational Site
      • Pismo Beach, California, Forenede Stater, 93449
        • Pfizer Investigational Site
      • Santa Ana, California, Forenede Stater, 92705
        • Pfizer Investigational Site
      • Walnut Creek, California, Forenede Stater, 94598
        • Pfizer Investigational Site
      • Whittier, California, Forenede Stater, 90601
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Pfizer Investigational Site
    • Connecticut
      • Stratford, Connecticut, Forenede Stater, 06615
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Pfizer Investigational Site
    • Florida
      • Chiefland, Florida, Forenede Stater, 32680
        • Pfizer Investigational Site
      • Clearwater, Florida, Forenede Stater, 33761
        • Pfizer Investigational Site
      • Kissimmee, Florida, Forenede Stater, 34741
        • Pfizer Investigational Site
      • Miami, Florida, Forenede Stater, 33173
        • Pfizer Investigational Site
      • Ocala, Florida, Forenede Stater, 34471
        • Pfizer Investigational Site
      • Ocala, Florida, Forenede Stater, 34474
        • Pfizer Investigational Site
      • Palm Harbor, Florida, Forenede Stater, 34684
        • Pfizer Investigational Site
      • Palm Springs, Florida, Forenede Stater, 33461
        • Pfizer Investigational Site
      • Plantation, Florida, Forenede Stater, 33324
        • Pfizer Investigational Site
      • Plantation, Florida, Forenede Stater, 33317
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, Forenede Stater, 33709
        • Pfizer Investigational Site
      • Sunrise, Florida, Forenede Stater, 33351
        • Pfizer Investigational Site
      • Tampa, Florida, Forenede Stater, 33609
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33409
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30328
        • Pfizer Investigational Site
    • Illinois
      • Gurnee, Illinois, Forenede Stater, 60031
        • Pfizer Investigational Site
      • Peoria, Illinois, Forenede Stater, 61614
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47714
        • Pfizer Investigational Site
      • Evansville, Indiana, Forenede Stater, 47712
        • Pfizer Investigational Site
      • Indianapolis, Indiana, Forenede Stater, 46254
        • Pfizer Investigational Site
    • Kansas
      • Prairie Village, Kansas, Forenede Stater, 66206
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Pfizer Investigational Site
      • Lexington, Kentucky, Forenede Stater, 40536
        • Pfizer Investigational Site
      • Lexington, Kentucky, Forenede Stater, 40536-0284
        • Pfizer Investigational Site
      • Owensboro, Kentucky, Forenede Stater, 42303
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Forenede Stater, 70114
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Forenede Stater, 70128
        • Pfizer Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01107
        • Pfizer Investigational Site
      • Worcester, Massachusetts, Forenede Stater, 01610
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater, 49009
        • Pfizer Investigational Site
      • Lansing, Michigan, Forenede Stater, 48917
        • Pfizer Investigational Site
    • Minnesota
      • Edina, Minnesota, Forenede Stater, 55435
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
        • Pfizer Investigational Site
    • Missouri
      • Blue Springs, Missouri, Forenede Stater, 64014
        • Pfizer Investigational Site
      • Springfield, Missouri, Forenede Stater, 65807
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89014
        • Pfizer Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08002
        • Pfizer Investigational Site
      • Edison, New Jersey, Forenede Stater, 08817
        • Pfizer Investigational Site
      • Highland Park, New Jersey, Forenede Stater, 08904
        • Pfizer Investigational Site
      • Ridgewood, New Jersey, Forenede Stater, 07450
        • Pfizer Investigational Site
      • South Eddison, New Jersey, Forenede Stater, 08817
        • Pfizer Investigational Site
    • New York
      • Albany, New York, Forenede Stater, 12205
        • Pfizer Investigational Site
      • Johnson City, New York, Forenede Stater, 13790
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater, 14618
        • Pfizer Investigational Site
      • Smithtown, New York, Forenede Stater, 11787-2817
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Forenede Stater, 28209
        • Pfizer Investigational Site
      • Raleigh, North Carolina, Forenede Stater, 27612
        • Pfizer Investigational Site
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Pfizer Investigational Site
      • Salisbury, North Carolina, Forenede Stater, 28144
        • 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
      • Mogadore, Ohio, Forenede Stater, 44260
        • Pfizer Investigational Site
      • Toledo, Ohio, Forenede Stater, 43623
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
        • Pfizer Investigational Site
      • Medford, Oregon, Forenede Stater, 97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Bensalem, Pennsylvania, Forenede Stater, 19020
        • Pfizer Investigational Site
      • Mechanicsburg, Pennsylvania, Forenede Stater, 17055
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15218
        • Pfizer Investigational Site
      • West Reading, Pennsylvania, Forenede Stater, 19611-1124
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406
        • Pfizer Investigational Site
      • Greenville, South Carolina, Forenede Stater, 29601
        • Pfizer Investigational Site
      • Greer, South Carolina, Forenede Stater, 29651
        • Pfizer Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37207
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Pfizer Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76107
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78217
        • Pfizer Investigational Site
    • Utah
      • Layton, Utah, Forenede Stater, 84041
        • Pfizer Investigational Site
      • Layton, Utah, Forenede Stater, 841041
        • Pfizer Investigational Site
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Pfizer Investigational Site
      • South Jordan, Utah, Forenede Stater, 84095
        • Pfizer Investigational Site
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23455
        • Pfizer Investigational Site
      • 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
      • Seattle, Washington, Forenede Stater, 98166-2967
        • Pfizer Investigational Site
      • Spokane, Washington, Forenede Stater, 99204
        • Pfizer Investigational Site
      • Yakima, Washington, Forenede Stater, 98902
        • Pfizer Investigational Site
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • 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:

  • At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites
  • At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale

Exclusion Criteria:

  • Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma)
  • Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening
  • Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)
  • Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
To evaluate the efficacy of pregabalin (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale

Sekundære resultatmål

Resultatmål
To evaluate the efficacy of pregabalin (BID) compared with placebo treatment to relieve pain and to improve global assessment, functional status, sleep and fatigue associated with fibromyalgia using questionnaires. To evaluate the longterm safety

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. april 2005

Studieafslutning (Faktiske)

1. juni 2006

Datoer for studieregistrering

Først indsendt

7. september 2005

Først indsendt, der opfyldte QC-kriterier

7. september 2005

Først opslået (Skøn)

9. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. januar 2021

Sidst verificeret

1. september 2006

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A0081059

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 .

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