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Study of Milnacipran for the Treatment of Fibromyalgia

18. december 2007 opdateret af: Forest Laboratories

A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia

Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

1200

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
      • Mobile, Alabama, Forenede Stater, 36608
        • Forest Investigative Site
      • Montgomery, Alabama, Forenede Stater, 36111
        • Forest Investigative Site
    • Arizona
      • Peoria, Arizona, Forenede Stater, 85381
        • Forest Investigative Site
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Forest Investigative Site
      • Sacramento, California, Forenede Stater, 95825
        • Forest Investigative Site
      • San Diego, California, Forenede Stater, 92117
        • Forest Investigative Site
      • San Diego, California, Forenede Stater, 92108
        • Forest Investigative Site
      • Santa Ana, California, Forenede Stater, 92705
        • Forest Investigative Site
      • Spring Valley, California, Forenede Stater, 91978
        • Forest Investigative Site
      • Torrance, California, Forenede Stater, 90505
        • Forest Investigative Site
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Forest Investigative Site
      • Colorado Springs, Colorado, Forenede Stater, 80910
        • Forest Investigative Site
    • Connecticut
      • Danbury, Connecticut, Forenede Stater, 06810
        • Forest Investigative Site
      • Stamford, Connecticut, Forenede Stater, 06905
        • Forest Investigative Site
      • Trumball, Connecticut, Forenede Stater, 06611
        • Forest Investigative Site
    • Florida
      • Clearwater, Florida, Forenede Stater, 33761
        • Forest Investigative Site
      • Deland, Florida, Forenede Stater, 32720
        • Forest Investigative Site
      • Delray Beach, Florida, Forenede Stater, 33484
        • Forest Investigative Site
      • Jacksonville, Florida, Forenede Stater, 33216
        • Forest Investigative Site
      • Ocala, Florida, Forenede Stater, 34471
        • Forest Investigative Site
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Forest Investigative Site
      • Palm Harbor, Florida, Forenede Stater, 34684
        • Forest Investigative Site
      • Pembroke Pines, Florida, Forenede Stater, 33029
        • Forest Investigative Site
      • Port Orange, Florida, Forenede Stater, 32127
        • Forest Investigative Site
      • Tamarac, Florida, Forenede Stater, 33321
        • Forest Investigative Site
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30033
        • Forest Investigative Site
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96814
        • Forest Investigative Site
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83642
        • Forest Investigative Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Forest Investigative Site
      • Libertyville, Illinois, Forenede Stater, 60048
        • Forest Investigative Site
      • Peoria, Illinois, Forenede Stater, 61614
        • Forest Investigative Site
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47713
        • Forest Investigative Site
      • Lafayette, Indiana, Forenede Stater, 47904
        • Forest Investigative Site
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67207
        • Forest Investigative Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Forest Investigative Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21237
        • Forest Investigative Site
      • Columbia, Maryland, Forenede Stater, 21045
        • Forest Investigative Site
      • Frederick, Maryland, Forenede Stater, 21702
        • Forest Investigative Site
    • Massachusetts
      • Newton, Massachusetts, Forenede Stater, 02462
        • Forest Investigative Site
      • North Dartmouth, Massachusetts, Forenede Stater, 02747
        • Forest Investigative Site
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater, 49009
        • Forest Investigative Site
    • Mississippi
      • Flowood, Mississippi, Forenede Stater, 39232
        • Forest Investigative Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63141
        • Forest Investigative Site
    • Montana
      • Missoula, Montana, Forenede Stater, 59802
        • Forest Investigative Site
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08002
        • Forest Investigative Site
      • Clementon, New Jersey, Forenede Stater, 08021
        • Forest Investigative Site
    • New Mexico
      • Santa Fe, New Mexico, Forenede Stater, 87505
        • Forest Investigative Site
    • New York
      • East Syracuse, New York, Forenede Stater, 13057
        • Forest Investigative Site
      • Great Neck, New York, Forenede Stater, 11021
        • Forest Investigative Site
      • Rochester, New York, Forenede Stater, 14618
        • Forest Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28209
        • Forest Investigative Site
      • Fayetteville, North Carolina, Forenede Stater, 28304
        • Forest Investigative Site
      • Hickory, North Carolina, Forenede Stater, 28601
        • Forest Investigative Site
      • Raleigh, North Carolina, Forenede Stater, 27612
        • Forest Investigative Site
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Forest Investigative Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Forest Investigative Site
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Forest Investigative Site
    • Ohio
      • Marion, Ohio, Forenede Stater, 43302
        • Forest Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Forest Investigative Site
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Forest Investigative Site
      • Eugene, Oregon, Forenede Stater, 97404
        • Forest Investigative Site
      • Medford, Oregon, Forenede Stater, 97504
        • Forest Investigative Site
      • Portland, Oregon, Forenede Stater, 97205
        • Forest Investigative Site
    • Pennsylvania
      • Duncanville, Pennsylvania, Forenede Stater, 16635
        • Forest Investigative Site
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
        • Forest Investigative Site
    • South Carolina
      • Orangeburg, South Carolina, Forenede Stater, 29118
        • Forest Investigative Site
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Forest Investigative Site
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Forest Investigative Site
      • Memphis, Tennessee, Forenede Stater, 38119
        • Forest Investigative Site
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Forest Investigative Site
      • San Antonio, Texas, Forenede Stater, 78205
        • Forest Investigative Site
      • Sugarland, Texas, Forenede Stater, 77479
        • Forest Investigative Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23294
        • Forest Investigative Site
      • Virginia Beach, Virginia, Forenede Stater, 23454
        • Forest Investigative Site
    • Washington
      • Bellingham, Washington, Forenede Stater, 98226
        • Forest Investigative Site
      • Everett, Washington, Forenede Stater, 98201
        • Forest Investigative Site
      • Seattle, Washington, Forenede Stater, 98166
        • Forest Investigative Site
      • Wenatchee, Washington, Forenede Stater, 98801
        • 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

Exclusion Criteria:

  • Psychiatric illness
  • Depression
  • Suicidal risk
  • Substance abuse
  • Pulmonary dysfunction
  • Renal impairment
  • Active cardiac disease
  • Liver disease
  • Autoimmune disease
  • Cancer
  • Sleep apnea
  • Inflammatory bowel disease

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
Composite responder analysis based on pain and patient global status, with or without physical function.

Sekundære resultatmål

Resultatmål
Livskvalitet
Health Assessment Questionnaire (HAQ) Disability Index
Fatigue, sleep and cognitive assessments

Samarbejdspartnere og efterforskere

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

Sponsor

Forest Laboratories

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

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 2004

Studieafslutning

1. december 2006

Datoer for studieregistrering

Først indsendt

3. december 2004

Først indsendt, der opfyldte QC-kriterier

3. december 2004

Først opslået (Skøn)

6. december 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. december 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. december 2007

Sidst verificeret

1. december 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MLN-MD-02

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 milnacipran hydrochloride

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner