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Fesoterodine Flexible Dose Study

10. september 2009 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

896

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo (dobbeltblind)
Legemiddel: 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.
Eksperimentell: Fesoterodine (Double-Blind)
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2007

Primær fullføring (Faktiske)

1. mars 2008

Studiet fullført (Faktiske)

1. mars 2008

Datoer for studieregistrering

Først innsendt

25. september 2007

Først innsendt som oppfylte QC-kriteriene

25. september 2007

Først lagt ut (Anslag)

27. september 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. september 2009

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2009

Sist bekreftet

1. september 2009

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A0221014

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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