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Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

5. Oktober 2010 aktualisiert von: Pfizer

An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.

To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

153

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Japan
    • Chiba-ken
      • Inegeku, Chibashi, Chiba-ken, Japan
        • Pfizer Investigational Site
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan
        • Pfizer Investigational Site
      • Kaibara-cho, tanba-shi, Hyogo, Japan
        • Pfizer Investigational Site
    • Hyougo
      • Akashi-shi, Hyougo, Japan
        • Pfizer Investigational Site
      • Chuou-ku, koube-shi, Hyougo, Japan
        • Pfizer Investigational Site
      • Nishinomiya-shi, Hyougo, Japan
        • Pfizer Investigational Site
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan
        • Pfizer Investigational Site
    • Kanagawaken
      • Kawasakishi, Kanagawaken, Japan
        • Pfizer Investigational Site
    • Nara
      • Nara-shi, Nara, Japan
        • Pfizer Investigational Site
    • Osaka
      • Osaka-shi, Osaka, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Edogawa-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Shibuya-ku, Tokyo, Japan
        • Pfizer Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urinary urgency episodes >=1 per day.

Exclusion Criteria:

  • Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
  • Patient has a known neurological disease influencing bladder function.
  • Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Fesoterodine fumarate
Arzneimittel: fesoterodine fumarate
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
Zeitfenster: 52 Weeks
The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
52 Weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52
Zeitfenster: Week 4, 8, 28 and 52

The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Week 4, 8, 28 and 52
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52
Zeitfenster: Week 4, 8, 28 and 52

The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

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

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Week 4, 8, 28 and 52
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52
Zeitfenster: Week 4, 8, 28 and 52

The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Week 4, 8, 28 and 52
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52
Zeitfenster: Week 4, 8, 28 and 52

The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Week 4, 8, 28 and 52
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52
Zeitfenster: Week 4, 8, 28 and 52

The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Week 4, 8, 28 and 52
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52
Zeitfenster: Week 4, 8, 28 and 52

Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Week 4, 8, 28 and 52
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52
Zeitfenster: Week 28 and 52

KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.

KHQ consists of the following domains:

  • General health perceptions (GHP)
  • Impact on life
  • Role limitations
  • Physical limitations
  • Social limitations
  • Personal relationships (PR)
  • Emotions
  • Sleep/energy
  • Incontinence severity measures (ISM)

Change: mean at Week 28 and 52 minus mean at Baseline
Week 28 and 52
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52
Zeitfenster: Week 28 and 52

OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).

Change: mean at Week 28 and 52 minus mean at baseline
Week 28 and 52
The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage
Zeitfenster: Week 28 and 52

The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:

  1. no problems at all
  2. some very minor problems
  3. some minor problems
  4. some moderate problems
  5. severe problems
  6. many severe problems
Week 28 and 52
Change From Baseline in Grade of PPBC at Week 28 and 52
Zeitfenster: Week 28 and 52

The PPBC assessment was rated on a 6-point scale as follows:

  1. no problems at all
  2. some very minor problems
  3. some minor problems
  4. some moderate problems
  5. severe problems
  6. many severe problems

Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement.
Week 28 and 52

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2008

Primärer Abschluss (Tatsächlich)

1. August 2009

Studienabschluss (Tatsächlich)

1. August 2009

Studienanmeldedaten

Zuerst eingereicht

9. April 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. April 2008

Zuerst gepostet (Schätzen)

15. April 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

13. Oktober 2010

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Oktober 2010

Zuletzt verifiziert

1. Oktober 2010

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A0221006

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