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[S,S]-Reboxetine Dose-Range Finding Trial

7. juni 2011 opdateret af: Pfizer

[S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)

The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

280

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

    • Alabama
      • Huntsville, Alabama, Forenede Stater
        • Pfizer Investigational Site
    • Arizona
      • Chandler, Arizona, Forenede Stater
        • Pfizer Investigational Site
      • Mesa, Arizona, Forenede Stater
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater
        • Pfizer Investigational Site
      • Sun City, Arizona, Forenede Stater
        • Pfizer Investigational Site
      • Tucson, Arizona, Forenede Stater
        • Pfizer Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater
        • Pfizer Investigational Site
    • California
      • Arcadia, California, Forenede Stater
        • Pfizer Investigational Site
      • Fullerton, California, Forenede Stater
        • Pfizer Investigational Site
      • Irvine, California, Forenede Stater
        • Pfizer Investigational Site
      • Laguna Hills, California, Forenede Stater
        • Pfizer Investigational Site
      • Loma Linda, California, Forenede Stater
        • Pfizer Investigational Site
      • Orange, California, Forenede Stater
        • Pfizer Investigational Site
      • Redondo Beach, California, Forenede Stater
        • Pfizer Investigational Site
      • Whittier, California, Forenede Stater
        • Pfizer Investigational Site
    • Colorado
      • Boulder, Colorado, Forenede Stater
        • Pfizer Investigational Site
    • Florida
      • Bradenton, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Clearwater, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Ft. Myers, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Holly Hill, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Hollywood, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Kissimmee, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Largo, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Longwood, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Melbourne, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Ocala, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Oviedo, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Palm Beach Gardens, Florida, Forenede Stater
        • Pfizer Investigational Site
      • Plantation, Florida, Forenede Stater
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater
        • Pfizer Investigational Site
      • Oak Brook, Illinois, Forenede Stater
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, Forenede Stater
        • Pfizer Investigational Site
    • Kansas
      • Topeka, Kansas, Forenede Stater
        • Pfizer Investigational Site
    • Louisiana
      • Ruston, Louisiana, Forenede Stater
        • Pfizer Investigational Site
    • Maryland
      • Towson, Maryland, Forenede Stater
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Pfizer Investigational Site
      • Brockton, Massachusetts, Forenede Stater
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
        • Pfizer Investigational Site
    • Mississippi
      • Southaven, Mississippi, Forenede Stater
        • Pfizer Investigational Site
    • Missouri
      • Independence, Missouri, Forenede Stater
        • Pfizer Investigational Site
      • Kansas City, Missouri, Forenede Stater
        • Pfizer Investigational Site
      • Nixa, Missouri, Forenede Stater
        • Pfizer Investigational Site
      • Sprinfield, Missouri, Forenede Stater
        • Pfizer Investigational Site
      • St. Louis, Missouri, Forenede Stater
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, Forenede Stater
        • Pfizer Investigational Site
    • New Jersey
      • Clifton, New Jersey, Forenede Stater
        • Pfizer Investigational Site
      • Hackensack, New Jersey, Forenede Stater
        • Pfizer Investigational Site
      • Teaneck, New Jersey, Forenede Stater
        • Pfizer Investigational Site
    • New Mexico
      • Sante Fe, New Mexico, Forenede Stater
        • Pfizer Investigational Site
    • New York
      • Albany, New York, Forenede Stater
        • Pfizer Investigational Site
      • Amherst, New York, Forenede Stater
        • Pfizer Investigational Site
      • New York, New York, Forenede Stater
        • Pfizer Investigational Site
      • Orchard Park, New York, Forenede Stater
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, Forenede Stater
        • Pfizer Investigational Site
      • Raleigh, North Carolina, Forenede Stater
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater
        • Pfizer Investigational Site
    • North Dakota
      • Fargo, North Dakota, Forenede Stater
        • Pfizer Investigational Site
    • Ohio
      • Canfield, Ohio, Forenede Stater
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Forenede Stater
        • Pfizer Investigational Site
      • Cleveland, Ohio, Forenede Stater
        • Pfizer Investigational Site
      • Columbus, Ohio, Forenede Stater
        • Pfizer Investigational Site
      • Kettering, Ohio, Forenede Stater
        • Pfizer Investigational Site
      • Toledo, Ohio, Forenede Stater
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater
        • Pfizer Investigational Site
      • Altoona, Pennsylvania, Forenede Stater
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, Forenede Stater
        • Pfizer Investigational Site
    • Tennessee
      • Jackson, Tennessee, Forenede Stater
        • Pfizer Investigational Site
      • Kingsport, Tennessee, Forenede Stater
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, Forenede Stater
        • Pfizer Investigational Site
      • Richmond, Virginia, Forenede Stater
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Forenede Stater
        • Pfizer Investigational Site
      • Spokane, Washington, Forenede Stater
        • Pfizer Investigational Site
      • Tacoma, Washington, Forenede Stater
        • 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:

  • Patients must have pain present for more than 3 months after the healing of shingles skin rash
  • Patients at screening must have a score >/=40 mm on the pain visual analogue scale

Exclusion Criteria:

  • Patients with significant renal and hepatic impairment
  • Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
  • Patients with clinically abnormal electrocardiogram

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
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated

Sekundære resultatmål

Resultatmål
- The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey

Samarbejdspartnere og efterforskere

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

Sponsor

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.

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. marts 2006

Studieafslutning (Faktiske)

1. februar 2007

Datoer for studieregistrering

Først indsendt

7. februar 2006

Først indsendt, der opfyldte QC-kriterier

7. februar 2006

Først opslået (Skøn)

8. februar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. juni 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2011

Sidst verificeret

1. juni 2011

Mere information

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 Smerte

Kliniske forsøg med [S,S]-Reboxetin

Abonner