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An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.

6. april 2011 opdateret af: Pfizer

An 8-Week, Multi-Centre,Randomised Double-Blind, Placebo Controlled, Parallel Group Study To Evaluate The Efficacy,Toleration And Safety Of (+)- [S,S]- Reboxetine In The Treatment Of Stress Urinary Incontinence (SUI) In Women.

A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

402

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V-1N1
        • Pfizer Investigational Site
      • Victoria, British Columbia, Canada, V8T5G1
        • Pfizer Investigational Site
    • Ontario
      • Kitchener, Ontario, Canada, N2M 5N4
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3S 1Z1
        • Pfizer Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
  • Forenede Stater
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Pfizer Investigational Site
    • Arizona
      • Sun City, Arizona, Forenede Stater, 85351
        • Pfizer Investigational Site
      • Tucson, Arizona, Forenede Stater, 85712
        • Pfizer Investigational Site
      • Tucson, Arizona, Forenede Stater, 85712-5803
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Pfizer Investigational Site
    • California
      • Atherton, California, Forenede Stater, 94027
        • Pfizer Investigational Site
      • Carmichael, California, Forenede Stater, 95608
        • Pfizer Investigational Site
      • Laguna Woods, California, Forenede Stater, 92653
        • Pfizer Investigational Site
      • Murrieta, California, Forenede Stater, 92562
        • Pfizer Investigational Site
      • Newport Beach, California, Forenede Stater, 92660
        • Pfizer Investigational Site
      • Sacramento, California, Forenede Stater, 95825
        • Pfizer Investigational Site
      • San Diego, California, Forenede Stater, 92103
        • Pfizer Investigational Site
      • Tarzana, California, Forenede Stater, 91356
        • Pfizer Investigational Site
      • Temecula, California, Forenede Stater, 92591
        • Pfizer Investigational Site
      • Torrance, California, Forenede Stater, 90505
        • Pfizer Investigational Site
      • Vista, California, Forenede Stater, 92084
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Pfizer Investigational Site
      • Denver, Colorado, Forenede Stater, 80220
        • Pfizer Investigational Site
      • Denver, Colorado, Forenede Stater, 80210
        • Pfizer Investigational Site
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Pfizer Investigational Site
    • Connecticut
      • New London, Connecticut, Forenede Stater, 06320
        • Pfizer Investigational Site
      • Waterbury, Connecticut, Forenede Stater, 06708
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, Forenede Stater, 33180
        • Pfizer Investigational Site
      • New Port Richey, Florida, Forenede Stater, 34652
        • Pfizer Investigational Site
      • Panama City, Florida, Forenede Stater, 32405
        • Pfizer Investigational Site
      • Panama City, Florida, Forenede Stater, 32407
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, Forenede Stater, 33028
        • Pfizer Investigational Site
      • Port Richey, Florida, Forenede Stater, 34668
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Pfizer Investigational Site
    • Georgia
      • Alpharetta, Georgia, Forenede Stater, 30005
        • Pfizer Investigational Site
    • Idaho
      • Coeur D Alene, Idaho, Forenede Stater, 83814
        • Pfizer Investigational Site
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60004
        • Pfizer Investigational Site
      • Chicago, Illinois, Forenede Stater, 60616
        • Pfizer Investigational Site
      • Melrose Park, Illinois, Forenede Stater, 60160
        • Pfizer Investigational Site
    • Indiana
      • Greenwood, Indiana, Forenede Stater, 46143
        • Pfizer Investigational Site
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50309
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40291
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71106
        • Pfizer Investigational Site
    • Maryland
      • Greenbelt, Maryland, Forenede Stater, 20770
        • Pfizer Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, Forenede Stater, 02472
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
        • Pfizer Investigational Site
      • Jackson, Mississippi, Forenede Stater, 39216
        • Pfizer Investigational Site
    • Missouri
      • Liberty, Missouri, Forenede Stater, 64068
        • Pfizer Investigational Site
      • North Kansas City, Missouri, Forenede Stater, 64116
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89014
        • Pfizer Investigational Site
    • New Jersey
      • Edison, New Jersey, Forenede Stater, 08837
        • Pfizer Investigational Site
      • West Orange, New Jersey, Forenede Stater, 07052
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108
        • Pfizer Investigational Site
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Pfizer Investigational Site
      • Garden City, New York, Forenede Stater, 11530
        • Pfizer Investigational Site
      • Garden City, New York, Forenede Stater, 11530-1630
        • Pfizer Investigational Site
      • Mineola, New York, Forenede Stater, 11501
        • Pfizer Investigational Site
      • Poughkeepsie, New York, Forenede Stater, 12601
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, Forenede Stater, 27215
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Pfizer Investigational Site
      • Concord, North Carolina, Forenede Stater, 28025
        • Pfizer Investigational Site
      • Fayetteville, North Carolina, Forenede Stater, 28304
        • Pfizer Investigational Site
      • Winston-salem, North Carolina, Forenede Stater, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • Pfizer Investigational Site
    • Oklahoma
      • Bethany, Oklahoma, Forenede Stater, 73008
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
        • Pfizer Investigational Site
      • Eugene, Oregon, Forenede Stater, 97401-2676
        • Pfizer Investigational Site
      • Medford, Oregon, Forenede Stater, 97504
        • Pfizer Investigational Site
      • Portland, Oregon, Forenede Stater, 97239
        • Pfizer Investigational Site
    • Pennsylvania
      • Colmar, Pennsylvania, Forenede Stater, 18915
        • Pfizer Investigational Site
      • Lancaster, Pennsylvania, Forenede Stater, 17604
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Pfizer Investigational Site
      • Sellersville, Pennsylvania, Forenede Stater, 18960
        • Pfizer Investigational Site
      • Sewickley, Pennsylvania, Forenede Stater, 15143
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02904
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Pfizer Investigational Site
      • Columbia, South Carolina, Forenede Stater, 29201
        • Pfizer Investigational Site
      • Greer, South Carolina, Forenede Stater, 29651
        • Pfizer Investigational Site
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920-1522
        • Pfizer Investigational Site
      • Knoxville, Tennessee, Forenede Stater, 37920
        • Pfizer Investigational Site
    • Texas
      • Corpus Christi, Texas, Forenede Stater, 78414
        • Pfizer Investigational Site
      • Corsicana, Texas, Forenede Stater, 75110
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77024
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Pfizer Investigational Site
      • Sandy, Utah, Forenede Stater, 84070
        • Pfizer Investigational Site
      • Sandy, Utah, Forenede Stater, 84094
        • Pfizer Investigational Site
      • West Jordan, Utah, Forenede Stater, 84088
        • Pfizer Investigational Site
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23454
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • 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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Clinically significant stress urinary incontinence

Exclusion Criteria:

  • History or evidence of any relevant confounding urological or neurological 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
Proof of concept study to assess the efficacy, tolerability and safety of SS-RBX vs. placebo in the treatment of SUI.

Sekundære resultatmål

Resultatmål
To evaluate whether an upward dose adjustment affects the tolerability of SS-RBX.

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

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. november 2004

Primær færdiggørelse (Faktiske)

1. august 2006

Studieafslutning (Faktiske)

1. august 2006

Datoer for studieregistrering

Først indsendt

26. august 2005

Først indsendt, der opfyldte QC-kriterier

26. august 2005

Først opslået (Skøn)

30. august 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. april 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2011

Sidst verificeret

1. april 2011

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A6061023

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 Urininkontinens, stress

Kliniske forsøg med SS-RBX

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uganda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner