Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Chiba-ken
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Inegeku, Chibashi, Chiba-ken, Japonsko
- Pfizer Investigational Site
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Hyogo
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Amagasaki-shi, Hyogo, Japonsko
- Pfizer Investigational Site
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Kaibara-cho, tanba-shi, Hyogo, Japonsko
- Pfizer Investigational Site
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Hyougo
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Akashi-shi, Hyougo, Japonsko
- Pfizer Investigational Site
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Chuou-ku, koube-shi, Hyougo, Japonsko
- Pfizer Investigational Site
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Nishinomiya-shi, Hyougo, Japonsko
- Pfizer Investigational Site
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Kanagawa
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Sagamihara-shi, Kanagawa, Japonsko
- Pfizer Investigational Site
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Kanagawaken
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Kawasakishi, Kanagawaken, Japonsko
- Pfizer Investigational Site
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Nara
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Nara-shi, Nara, Japonsko
- Pfizer Investigational Site
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Osaka
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Osaka-shi, Osaka, Japonsko
- Pfizer Investigational Site
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Tokyo
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Edogawa-ku, Tokyo, Japonsko
- Pfizer Investigational Site
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Shibuya-ku, Tokyo, Japonsko
- Pfizer Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Fesoterodine fumarate
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4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
Časové okno: 52 Weeks
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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.
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52 Weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52
Časové okno: Week 4, 8, 28 and 52
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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
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Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52
Časové okno: Week 4, 8, 28 and 52
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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
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Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52
Časové okno: Week 4, 8, 28 and 52
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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
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Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52
Časové okno: Week 4, 8, 28 and 52
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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
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Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52
Časové okno: Week 4, 8, 28 and 52
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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
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Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52
Časové okno: Week 4, 8, 28 and 52
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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
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Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52
Časové okno: Week 28 and 52
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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:
Change: mean at Week 28 and 52 minus mean at Baseline |
Week 28 and 52
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Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52
Časové okno: Week 28 and 52
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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
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The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage
Časové okno: Week 28 and 52
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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:
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Week 28 and 52
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Change From Baseline in Grade of PPBC at Week 28 and 52
Časové okno: Week 28 and 52
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The PPBC assessment was rated on a 6-point scale as follows:
Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement. |
Week 28 and 52
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Urologická onemocnění
- Onemocnění močového měchýře
- Příznaky dolních močových cest
- Urologické projevy
- Močový měchýř, hyperaktivní
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Muskarinoví antagonisté
- Cholinergní antagonisté
- Cholinergní činidla
- Urologická činidla
- Fesoterodin
Další identifikační čísla studie
- A0221006
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