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.

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: fesoterodine fumarate

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

Study Locations

• 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fesoterodine fumarate	Drug: fesoterodine fumarate; 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: April 9, 2008
• First Submitted That Met QC Criteria: April 14, 2008
• First Posted (Estimate): April 15, 2008

Study Record Updates

• Last Update Posted (Estimate): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 5, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Fesoterodine
• Other Study ID Numbers: A0221006