Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

En undersøgelse af duloxetin i behandlingen af ​​fibromyalgi

16. maj 2007 opdateret af: Eli Lilly and Company

En 1-årig sikkerhedsundersøgelse af duloxetin hos patienter med fibromyalgi syndrom

Denne undersøgelse er designet til at evaluere duloxetin til behandling af fibromyalgi syndrom patienter.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

320

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Capital Federal, Argentina
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
  • Australien
      • Hobart, Australien
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
      • Melbourne, Australien
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
    • Queensland
      • Cotton Tree, Queensland, Australien, 4558
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
    • Victoria
      • Malvern, Victoria, Australien, 3144
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
  • Brasilien
      • Curitiba, Brasilien, 80060-240
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Goiania, Brasilien, 74043-110
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
      • Recife, Brasilien, 52020-010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
      • Rio de Janeiro, Brasilien, 20551-030
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
      • Sao Paulo, Brasilien
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Toronto, Ontario, Canada, M5T 3A9
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • Mexico
      • Guadalajara, Mexico
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday -Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
      • Mexico City, Mexico
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday -Friday from 9:00AM to 5:00PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
    • Michoacan
      • Morelia, Michoacan, Mexico
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
    • Yucatan
      • Merida, Yucatan, Mexico
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
  • Polen
      • Lublin, Polen
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
      • Poznan, Polen
        • For additional information regarding investigative sites for this trial. contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
      • Szczecin, Polen
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
      • Wroclaw, Polen
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
  • Taiwan
      • Kaohsiung, Taiwan
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician
      • Taichung, Taiwan
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your person physician
      • Taipei, Taiwan
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours , EST ) or speak with your personal physician
      • Tao-Yuan, Taiwan
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

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, OLDER_ADULT)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

  • Opfyld kriterier for primært fibromyalgisyndrom som defineret af American College of Rheumatologists

Ekskluderingskriterier:

  • Behandling med en monoaminoxidasehæmmer inden for 14 dage før besøg 2 eller det potentielle behov for at tage inden for 5 dage efter afbrydelse af undersøgelsen.
  • Alle patienter vurderet af deres læger til at være i alvorlig suicidalrisiko.
  • Har ukontrolleret snævervinklet glaukom

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: TILFÆLDIGT
  • Interventionel model: PARALLEL
  • Maskning: DOBBELT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Evaluer sikkerhed og effekt af duloxetin hos patienter diagnosticeret med fibromyalgi syndrom

Sekundære resultatmål

Resultatmål
Evaluer persistens af effektivitet
Evaluer langsigtede forskelle i effektivitet i forskellige doser
Evaluer gevinster i effektivitet hos ikke-responderere

Samarbejdspartnere og efterforskere

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

Sponsor

Eli Lilly and Company

Samarbejdspartnere

Boehringer Ingelheim

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.

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. juli 2005

Studieafslutning (FAKTISKE)

1. marts 2007

Datoer for studieregistrering

Først indsendt

29. juli 2005

Først indsendt, der opfyldte QC-kriterier

29. juli 2005

Først opslået (SKØN)

2. august 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (SKØN)

17. maj 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. maj 2007

Sidst verificeret

1. maj 2007

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 9075
  • F1J-MC-HMEH

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 duloxetin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bosnia & Herzegovina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner