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Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

20. januar 2011 opdateret af: Forest Laboratories

A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia

To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

364

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, 35205
        • Forest Investigative Site
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85210
        • Forest Investigative Site
      • Peoria, Arizona, Forenede Stater, 85381
        • Forest Investigative Site
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • Forest Investigative Site
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Forest Investigative Site
      • Sacramento, California, Forenede Stater, 95821
        • Forest Investigative Site
      • Sacramento, California, Forenede Stater, 95825
        • Forest Investigative Site
      • Torrance, California, Forenede Stater, 90505
        • Forest Investigative Site
      • Walnut Creek, California, Forenede Stater, 94598
        • Forest Investigative Site
    • Colorado
      • Denver, Colorado, Forenede Stater, 80239
        • Forest Investigative Site
    • Connecticut
      • Cromwell, Connecticut, Forenede Stater, 06416
        • Forest Investigative Site
      • Danbury, Connecticut, Forenede Stater, 06810
        • Forest Investigative Site
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Forest Investigative Site
      • Daytona Beach, Florida, Forenede Stater, 32117
        • Forest Investigative Site
      • Delray Beach, Florida, Forenede Stater, 33484
        • Forest Investigative Site
      • Fort Myers, Florida, Forenede Stater, 33912
        • Forest Investigative Site
      • Jacksonville, Florida, Forenede Stater, 32216
        • Forest Investigative Site
      • Miami, Florida, Forenede Stater, 33169
        • Forest Investigative Site
      • Ocala, Florida, Forenede Stater, 34471
        • Forest Investigative Site
      • Orlando, Florida, Forenede Stater, 32806
        • Forest Investigative Site
      • Orlando, Florida, Forenede Stater, 32806
        • Forest Investigative Site Orl2
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Forest Investigative Site
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • Forest Investigative Site PP1
      • Pembroke Pines, Florida, Forenede Stater, 33029
        • Forest Investigative Site PP2
      • Pismo Beach, Florida, Forenede Stater, 93449
        • Forest Investigative Site
      • St. Petersburg, Florida, Forenede Stater, 33709
        • Forest Investigative Site
      • Tampa, Florida, Forenede Stater, 33614
        • Forest Investigative Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30328
        • Forest Investigative Site
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96814
        • Forest Investigative Site
    • Idaho
      • Couer D'Alene, Idaho, Forenede Stater, 83814
        • Forest Investigative Site
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47713
        • Forest Investigative Site
      • Indianapolis, Indiana, Forenede Stater, 46254
        • Forest Investigative Site
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Forest Investigative Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21208
        • Forest Investigative Site
    • Massachusetts
      • No. Dartmouth, Massachusetts, Forenede Stater, 02747
        • Forest Investigative Site
      • Worcester, Massachusetts, Forenede Stater, 01610
        • Forest Investigative Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
        • Forest Investigative Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63141
        • Forest Investigative Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68134
        • Forest Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108
        • Forest Investigative Site
    • New York
      • Syracuse, New York, Forenede Stater, 13210
        • Forest Investigative Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Forest Investigative Site
      • Cleveland, Ohio, Forenede Stater, 44122
        • Forest Investigative Site
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97404
        • Forest Investigative Site
      • Medford, Oregon, Forenede Stater, 97504
        • Forest Investigative Site
      • Portland, Oregon, Forenede Stater, 97210
        • Forest Investigative Site
    • South Carolina
      • Greer, South Carolina, Forenede Stater, 29651
        • Forest Investigative Site
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Forest Investigative Site
    • Texas
      • Houston, Texas, Forenede Stater, 77074
        • Forest Investigative Site
      • Houston, Texas, Forenede Stater, 77104
        • Forest Investigative Site
      • Lake Jackson, Texas, Forenede Stater, 77566
        • Forest Investigative Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84102
        • Forest Investigative Site
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Forest Investigative Site
    • Vermont
      • Woodstock, Vermont, Forenede Stater, 05091
        • Forest Investigative Site
    • Washington
      • Bellevue, Washington, Forenede Stater, 98004
        • Forest Investigative Site
      • Bellingham, Washington, Forenede Stater, 98226
        • Forest Investigative Site
      • Seattle, Washington, Forenede Stater, 98104
        • Forest Investigative Site SEA1
      • Seattle, Washington, Forenede Stater, 98104
        • Forest Investigative Site SEA2
      • Spokane, Washington, Forenede Stater, 99204
        • Forest Investigative Site
    • Wisconsin
      • Racine, Wisconsin, Forenede Stater, 53406
        • Forest Investigative 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 til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
  • tolerate at least 300 mg/day of pregabalin
  • have an incomplete response to pregabalin treatment

Exclusion Criteria:

  • suicidal risk
  • substance abuse
  • pulmonary dysfunction
  • renal impairment
  • active cardiac disease
  • liver disease
  • narrow angle glaucoma
  • autoimmune disease
  • cancer
  • inflammatory bowel disease
  • unstable endocrine disease
  • prostatic enlargement

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Milnacipran Added
Medicin: Milnacipran Added
Milnacipran 100 mg/d added
Eksperimentel: No Treatment Added
Medicin: No Treatment Added
No added treatment
Andre navne:
  • Lyrica (r)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Global Impression of Change (PGIC) Responder Rate at End of Study
Tidsramme: End of Randomized treatment period (11 weeks)
The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.
End of Randomized treatment period (11 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study
Tidsramme: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)
The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).
Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)

Samarbejdspartnere og efterforskere

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

Sponsor

Forest Laboratories

Efterforskere

  • Studieleder: Patricia D'Astoli, Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

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. november 2008

Primær færdiggørelse (Faktiske)

1. november 2009

Studieafslutning (Faktiske)

1. januar 2010

Datoer for studieregistrering

Først indsendt

24. november 2008

Først indsendt, der opfyldte QC-kriterier

24. november 2008

Først opslået (Skøn)

25. november 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. februar 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. januar 2011

Sidst verificeret

1. januar 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MLN-MD-15

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 .

Abonner