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Fesoterodine Flexible Dose Study

10. september 2009 opdateret af: Pfizer

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

896

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
      • Mobile, Alabama, Forenede Stater, 36608
        • Pfizer Investigational Site
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85225
        • Pfizer Investigational Site
      • Peoria, Arizona, Forenede Stater, 85381
        • Pfizer Investigational Site
      • Tucson, Arizona, Forenede Stater, 85741
        • Pfizer Investigational Site
    • California
      • Rancho Cordova, California, Forenede Stater, 95670
        • Pfizer Investigational Site
      • Sacramento, California, Forenede Stater, 95825
        • Pfizer Investigational Site
      • San Diego, California, Forenede Stater, 92103
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Pfizer Investigational Site
      • Denver, Colorado, Forenede Stater, 80210
        • Pfizer Investigational Site
      • Denver, Colorado, Forenede Stater, 80211
        • Pfizer Investigational Site
      • Englewood, Colorado, Forenede Stater, 80112
        • Pfizer Investigational Site
    • Connecticut
      • New Britain, Connecticut, Forenede Stater, 06052
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, Forenede Stater, 33180
        • Pfizer Investigational Site
      • Bonita Springs, Florida, Forenede Stater, 34134
        • Pfizer Investigational Site
      • Hollywood, Florida, Forenede Stater, 33021
        • Pfizer Investigational Site
      • Lake Worth, Florida, Forenede Stater, 33461
        • Pfizer Investigational Site
      • Miami, Florida, Forenede Stater, 33176
        • Pfizer Investigational Site
      • Miami, Florida, Forenede Stater, 33143
        • Pfizer Investigational Site
      • Naples, Florida, Forenede Stater, 34102
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • Pfizer Investigational Site
      • St. Petersburg, Florida, Forenede Stater, 33709
        • Pfizer Investigational Site
      • Stuart, Florida, Forenede Stater, 34996
        • Pfizer Investigational Site
      • Tallahassee, Florida, Forenede Stater, 32308
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60610
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47713
        • Pfizer Investigational Site
      • Jeffersonville, Indiana, Forenede Stater, 47130
        • Pfizer Investigational Site
      • Newburgh, Indiana, Forenede Stater, 47630
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66215
        • Pfizer Investigational Site
      • Overland Park, Kansas, Forenede Stater, 66210
        • Pfizer Investigational Site
      • Pratt, Kansas, Forenede Stater, 67124
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Pfizer Investigational Site
      • Louisville, Kentucky, Forenede Stater, 40207
        • Pfizer Investigational Site
      • Louisville, Kentucky, Forenede Stater, 40291
        • Pfizer Investigational Site
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21204
        • Pfizer Investigational Site
      • Bel Air, Maryland, Forenede Stater, 21014
        • Pfizer Investigational Site
    • Massachusetts
      • Milford, Massachusetts, Forenede Stater, 01757
        • Pfizer Investigational Site
      • Springfield, Massachusetts, Forenede Stater, 01103
        • Pfizer Investigational Site
      • West Yarmouth, Massachusetts, Forenede Stater, 02673
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48103
        • Pfizer Investigational Site
      • Paw Paw, Michigan, Forenede Stater, 49079
        • Pfizer Investigational Site
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Pfizer Investigational Site
      • Troy, Michigan, Forenede Stater, 48098
        • Pfizer Investigational Site
    • Mississippi
      • Picayune, Mississippi, Forenede Stater, 39466
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63117
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68506
        • Pfizer Investigational Site
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Pfizer Investigational Site
      • Omaha, Nebraska, Forenede Stater, 68114
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89104
        • Pfizer Investigational Site
      • Las Vegas, Nevada, Forenede Stater, 89130
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Pfizer Investigational Site
    • New York
      • Garden City, New York, Forenede Stater, 11530
        • Pfizer Investigational Site
      • Kingston, New York, Forenede Stater, 12401
        • Pfizer Investigational Site
      • Manlius, New York, Forenede Stater, 13104
        • Pfizer Investigational Site
      • New York, New York, Forenede Stater, 10016
        • Pfizer Investigational Site
      • Poughkeepsie, New York, Forenede Stater, 12601
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater, 14609
        • Pfizer Investigational Site
      • Syracuse, New York, Forenede Stater, 13210
        • Pfizer Investigational Site
      • Williamsville, New York, Forenede Stater, 14221
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27518
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Pfizer Investigational Site
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Forenede Stater, 45249
        • Pfizer Investigational Site
    • Oklahoma
      • Bethany, Oklahoma, Forenede Stater, 73008
        • Pfizer Investigational Site
      • Norman, Oklahoma, Forenede Stater, 73071
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Pfizer Investigational Site
    • Pennsylvania
      • Lansdale, Pennsylvania, Forenede Stater, 19446
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19115
        • Pfizer Investigational Site
      • Sellersville, Pennsylvania, Forenede Stater, 18960
        • Pfizer Investigational Site
      • State College, Pennsylvania, Forenede Stater, 16801
        • Pfizer Investigational Site
    • Rhode Island
      • Cranston, Rhode Island, Forenede Stater, 02920
        • Pfizer Investigational Site
      • Cumberland, Rhode Island, Forenede Stater, 02864
        • Pfizer Investigational Site
      • Warwick, Rhode Island, Forenede Stater, 02886
        • Pfizer Investigational Site
    • South Carolina
      • Mt. Pleasant, South Carolina, Forenede Stater, 29464
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Pfizer Investigational Site
      • Johnson City, Tennessee, Forenede Stater, 37601
        • Pfizer Investigational Site
      • Johnson City, Tennessee, Forenede Stater, 36701
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37203
        • Pfizer Investigational Site
      • New Tazewell, Tennessee, Forenede Stater, 37825
        • Pfizer Investigational Site
    • Texas
      • Bryan, Texas, Forenede Stater, 77802
        • Pfizer Investigational Site
      • Corpus Christi, Texas, Forenede Stater, 78414
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75231
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77079
        • Pfizer Investigational Site
      • Longview, Texas, Forenede Stater, 75605
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
    • Virginia
      • Arlington, Virginia, Forenede Stater, 22205
        • Pfizer Investigational Site
      • Norfolk, Virginia, Forenede Stater, 23502
        • Pfizer Investigational Site
      • Richmond, Virginia, Forenede Stater, 23294
        • Pfizer Investigational Site
    • Washington
      • Mountlake Terrace, Washington, Forenede Stater, 98043
        • Pfizer Investigational Site
      • Spokane, Washington, Forenede Stater, 99207
        • 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:

  • Overactive bladder symptoms for greater than or equal to 3 months.
  • Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
  • Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

  • Contraindication to fesoterodine (antimuscarinics).
  • Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
  • Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
  • Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo (dobbeltblind)
Medicin: Placebo
Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
Eksperimentel: Fesoterodine (Double-Blind)
Medicin: Fesoterodine
4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.
Tidsramme: Baseline and Week 12

The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.

Change: mean at Week 12 minus mean at Baseline
Baseline and Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline
Tidsramme: Baseline, Week 2 and Week 6

The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.

Change: mean at observation minus mean at baseline
Baseline, Week 2 and Week 6
Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline
Tidsramme: Baseline, Week 2, Week 6 and Week 12
Change in number of urgency episodes (urinary sensation scale [USS] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.
Baseline, Week 2, Week 6 and Week 12
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline
Tidsramme: Baseline, Week 2, Week 6 and Week 12
Change in number of severe urgency episodes (urinary sensation scale [USS] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.
Baseline, Week 2, Week 6 and Week 12
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline
Tidsramme: Baseline, Week 2, Week 6 and Week 12
Change in number of UUI episodes (urinary sensation scale [USS] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine
Baseline, Week 2, Week 6 and Week 12
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline
Tidsramme: Baseline, Week 2, Week 6 and Week 12
Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.
Baseline, Week 2, Week 6 and Week 12
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline
Tidsramme: Baseline, Week 2, Week 6 and Week 12
Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit
Baseline, Week 2, Week 6 and Week 12
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline
Tidsramme: Baseline, Week 2, Week 6 and Week 12
Change in frequency urgency sum is total urinary sensation scale (USS) ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold:leak urine. Numerical decrease indicates improvement
Baseline, Week 2, Week 6 and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale
Tidsramme: Baseline and Week 12

Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement.

Change: mean at Week 12 minus mean at baseline
Baseline and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
Tidsramme: Baseline and Week 12

Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement.

Change: mean at Week 12 minus mean at baseline.
Baseline and Week 12
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Tidsramme: Baseline, Week 2, Week 6 and Week 12
PPBC scale range: 1='does not cause me any problems at all' to 6='causes me many severe problems'. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline
Baseline, Week 2, Week 6 and Week 12
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Tidsramme: Baseline, Week 2, Week 6 and Week 12
UPS scores range from 0 ("I am usually not able to hold urine") to 2 ("I am usually able to finish what I am doing before going to the toilet [without leaking]"). Improvement: positive score change; No change: score change=0; Deterioration: negative score change
Baseline, Week 2, Week 6 and Week 12
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline
Tidsramme: Baseline, Week 2, Week 6 and Week 12

The urgency severity VAS Scale records the subject's assessment of the severity of urgency. VAS scale ranges from 1 'Very Mild' to 10 'Very Severe'. Negative change indicated improvement.

Change: mean at observation minus mean at baseline.
Baseline, Week 2, Week 6 and Week 12

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. august 2007

Primær færdiggørelse (Faktiske)

1. marts 2008

Studieafslutning (Faktiske)

1. marts 2008

Datoer for studieregistrering

Først indsendt

25. september 2007

Først indsendt, der opfyldte QC-kriterier

25. september 2007

Først opslået (Skøn)

27. september 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. september 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2009

Sidst verificeret

1. september 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A0221014

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 Fesoterodine

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Africa

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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