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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
fesoterodine fumarate
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fesoterodine fumarate

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
April 9, 2008
Last Updated
October 5, 2010
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00658684
Brief Title
Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
Official Title
An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fesoterodine fumarate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fesoterodine fumarate
Intervention Description
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
Primary Outcome Measure Information:
Title
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
Description
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.
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52
Description
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
Time Frame
Week 4, 8, 28 and 52
Title
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52
Description
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
Time Frame
Week 4, 8, 28 and 52
Title
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52
Description
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
Time Frame
Week 4, 8, 28 and 52
Title
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52
Description
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
Time Frame
Week 4, 8, 28 and 52
Title
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52
Description
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
Time Frame
Week 4, 8, 28 and 52
Title
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52
Description
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
Time Frame
Week 4, 8, 28 and 52
Title
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52
Description
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
Time Frame
Week 28 and 52
Title
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52
Description
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
Time Frame
Week 28 and 52
Title
The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage
Description
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
Time Frame
Week 28 and 52
Title
Change From Baseline in Grade of PPBC at Week 28 and 52
Description
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.
Time Frame
Week 28 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Inegeku, Chibashi
State/Province
Chiba-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Amagasaki-shi
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kaibara-cho, tanba-shi
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Akashi-shi
State/Province
Hyougo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chuou-ku, koube-shi
State/Province
Hyougo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nishinomiya-shi
State/Province
Hyougo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawasakishi
State/Province
Kanagawaken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sagamihara-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nara-shi
State/Province
Nara
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Edogawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shibuya-ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221006&StudyName=Long%20Term%20Study%20To%20Evaluate%20the%20Safety%2C%20Tolerability%20and%20Efficacy%20of%20Fesoterodine%20for%20Overactive%20Bladder.
Description
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Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

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