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

Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

4. oktober 2018 opdateret af: Pfizer

Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.

This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

823

Kontakter og lokationer

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

Studiesteder

  • Slovakiet
      • ?a?a, Slovakiet
        • Pfizer Investigational Site
      • Aa, Slovakiet
        • Pfizer Investigational Site
      • Adca, Slovakiet
        • Pfizer Investigational Site
      • B.Bystrica, Slovakiet
        • Pfizer Investigational Site
      • Banska Bystrica, Slovakiet, 974 01
        • Pfizer Investigational Site
      • Bardejov, Slovakiet
        • Pfizer Investigational Site
      • Bratislava, Slovakiet
        • Pfizer Investigational Site
      • Bratislava, Slovakiet, 82606
        • Pfizer Investigational Site
      • Bratislava, Slovakiet, 833 05
        • Pfizer Investigational Site
      • Bratislava, Slovakiet, 851 01
        • Pfizer Investigational Site
      • Bratislava, Slovakiet, 851 05
        • Pfizer Investigational Site
      • Bratislava 2, Slovakiet, 82109
        • Pfizer Investigational Site
      • Bratislava 2, Slovakiet, 82606
        • Pfizer Investigational Site
      • Bratislava 4, Slovakiet
        • Pfizer Investigational Site
      • Bratislava 5, Slovakiet, 85104
        • Pfizer Investigational Site
      • Bratislava 5, Slovakiet, 85107
        • Pfizer Investigational Site
      • Dolny Kubin, Slovakiet
        • Pfizer Investigational Site
      • Dunajska Streda, Slovakiet
        • Pfizer Investigational Site
      • Hlohovec, Slovakiet
        • Pfizer Investigational Site
      • Humenne, Slovakiet
        • Pfizer Investigational Site
      • Ilina, Slovakiet
        • Pfizer Investigational Site
      • Koice, Slovakiet
        • Pfizer Investigational Site
      • Koice-aca, Slovakiet
        • Pfizer Investigational Site
      • Komarno, Slovakiet
        • Pfizer Investigational Site
      • Kosice, Slovakiet, 041 90
        • Pfizer Investigational Site
      • Kosice, Slovakiet
        • Pfizer Investigational Site
      • Kraovsky Chlmec, Slovakiet
        • Pfizer Investigational Site
      • Liptovsky Hradok, Slovakiet
        • Pfizer Investigational Site
      • Liptovsky Mikulas, Slovakiet
        • Pfizer Investigational Site
      • Luenec, Slovakiet
        • Pfizer Investigational Site
      • Malacky, Slovakiet, 901 01
        • Pfizer Investigational Site
      • Malacky, Slovakiet, 90122
        • Pfizer Investigational Site
      • Martin, Slovakiet
        • Pfizer Investigational Site
      • Michalovce, Slovakiet
        • Pfizer Investigational Site
      • Myjava, Slovakiet
        • Pfizer Investigational Site
      • Namestovo, Slovakiet
        • Pfizer Investigational Site
      • Nitra, Slovakiet, 949 01
        • Pfizer Investigational Site
      • Nitra, Slovakiet, 951 01
        • Pfizer Investigational Site
      • Nitra, Slovakiet
        • Pfizer Investigational Site
      • Nove Zamky, Slovakiet
        • Pfizer Investigational Site
      • Nové Zámky, Slovakiet
        • Pfizer Investigational Site
      • Piestany, Slovakiet, 921 01
        • Pfizer Investigational Site
      • Poprad, Slovakiet
        • Pfizer Investigational Site
      • Povaska Bystrica, Slovakiet
        • Pfizer Investigational Site
      • Povazska Bystrica, Slovakiet, 017 01
        • Pfizer Investigational Site
      • Preov, Slovakiet
        • Pfizer Investigational Site
      • Prievidza, Slovakiet
        • Pfizer Investigational Site
      • Puchov, Slovakiet
        • Pfizer Investigational Site
      • Revuca, Slovakiet
        • Pfizer Investigational Site
      • Rimavska Sobota, Slovakiet
        • Pfizer Investigational Site
      • Ruomberok, Slovakiet
        • Pfizer Investigational Site
      • Ruzomberok, Slovakiet
        • Pfizer Investigational Site
      • Senica, Slovakiet, 90501
        • Pfizer Investigational Site
      • Skalica, Slovakiet, 90901
        • Pfizer Investigational Site
      • Sobrance, Slovakiet
        • Pfizer Investigational Site
      • SpisskaNova Ves, Slovakiet
        • Pfizer Investigational Site
      • Stropkov, Slovakiet
        • Pfizer Investigational Site
      • Svidnik, Slovakiet
        • Pfizer Investigational Site
      • Topoany, Slovakiet
        • Pfizer Investigational Site
      • Trebisov, Slovakiet
        • Pfizer Investigational Site
      • Trencin, Slovakiet, 911 01
        • Pfizer Investigational Site
      • Trenin, Slovakiet
        • Pfizer Investigational Site
      • Trnava, Slovakiet
        • Pfizer Investigational Site
      • Turianske Teplice, Slovakiet
        • Pfizer Investigational Site
      • Urany, Slovakiet
        • Pfizer Investigational Site
      • Vrable, Slovakiet
        • Pfizer Investigational Site
      • Vranov n/Topou, Slovakiet
        • Pfizer Investigational Site
      • Zvolen, Slovakiet
        • 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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Beskrivelse

Inclusion Criteria:

  • Patients older than 18 years
  • Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
  • Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome
  • Due to intolerance: persistent and/or unacceptable adverse events

Exclusion Criteria:

  • Hypersensitivity to the active substance or to peanut or soya or any of the excipients.
  • History of acute urinary retention (requiring catheterisation)
  • Gastric retention
  • Uncontrolled narrow angle glaucoma
  • Myasthenia gravis
  • Severe hepatic impairment (Child Pugh C)
  • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
  • Severe ulcerative colitis
  • Toxic megacolon.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
fesoterodine
Medicin: fesoterodine
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment
Andre navne:
  • TOVIAZ

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit
Tidsramme: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.
Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4
Tidsramme: Baseline, Month 1, Month 2, Month 3 or ET
Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.
Baseline, Month 1, Month 2, Month 3 or ET
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4
Tidsramme: Baseline, Month 1, Month 2, Month 3 or ET
UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).
Baseline, Month 1, Month 2, Month 3 or ET
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4
Tidsramme: Baseline, Month 1, Month 2, Month 3 or ET
The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.
Baseline, Month 1, Month 2, Month 3 or ET

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4
Tidsramme: Baseline, Month 1, Month 2, Month 3 or ET
The PVR urine volume: measured by an ultrasound scan.
Baseline, Month 1, Month 2, Month 3 or ET
Patient's Global Evaluation of Fesoterodine
Tidsramme: Baseline, Month 3 or ET
The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.
Baseline, Month 3 or ET
Clinical Global Evaluation of Fesoterodine
Tidsramme: 12 weeks
Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'
12 weeks
Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4
Tidsramme: Month 3 or ET
Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.
Month 3 or ET
Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale
Tidsramme: Baseline, Month 3 or ET
Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Baseline, Month 3 or ET
Change From Baseline in Total Scores of OAB-q at Visit 4
Tidsramme: Baseline, Month 3 or ET
Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Baseline, Month 3 or ET
Time To Onset Of Treatment Response
Tidsramme: Month 1, Month 2, Month 3 or ET
Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.
Month 1, Month 2, Month 3 or ET
Study Doses
Tidsramme: Month 3 or ET
Number of subjects that changed doses throughout the study period.
Month 3 or ET
Reasons for Study Treatment Dose Changes
Tidsramme: Month 3 or ET
Possible change in the dose and the reasons for the change were collected and documented.
Month 3 or ET

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. juli 2008

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

3. juni 2008

Først indsendt, der opfyldte QC-kriterier

4. juni 2008

Først opslået (Skøn)

5. juni 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A0221059

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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kyrgyzstan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner