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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658684
• Other study ID #: A0221006
• Secondary ID: A0221006
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2008
• Last updated: October 5, 2010
• Start date: February 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• fesoterodine fumarate
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume	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	Yes
Secondary	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at 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	No
Secondary	Change From Baseline in Mean Number of Micturitions at 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	No
Secondary	Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at 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	No
Secondary	Change From Baseline in Mean Incontinence Episodes Per 24 Hours at 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	No
Secondary	Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at 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	No
Secondary	Change From Baseline in Mean Voided Volume Per Micturition at 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	No
Secondary	Change From Baseline in Score of King's Health Questionnaire (KHQ) at 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	No
Secondary	Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at 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	No
Secondary	The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage	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: no problems at all; some very minor problems; some minor problems; some moderate problems; severe problems; many severe problems	Week 28 and 52	No
Secondary	Change From Baseline in Grade of PPBC at Week 28 and 52	The PPBC assessment was rated on a 6-point scale as follows: no problems at all; some very minor problems; some minor problems; some moderate problems; severe problems; many severe problems; Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement.	Week 28 and 52	No

External Links

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