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

5 octobre 2010 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

153

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Fesoterodine fumarate
Médicament: fesoterodine fumarate
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2008

Achèvement primaire (Réel)

1 août 2009

Achèvement de l'étude (Réel)

1 août 2009

Dates d'inscription aux études

Première soumission

9 avril 2008

Première soumission répondant aux critères de contrôle qualité

14 avril 2008

Première publication (Estimation)

15 avril 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

13 octobre 2010

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 octobre 2010

Dernière vérification

1 octobre 2010

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • A0221006

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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