Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00561951
First received: November 19, 2007
Last updated: July 11, 2011
Last verified: July 2011
Results First Received: January 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Overactive Bladder
Interventions: Drug: fesoterodine fumarate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects who underwent screening were enrolled into the run-in period at visit 1 and received single-blind placebo for 2 weeks. At Visit 2, Only subjects with overactive bladder who met the criteria were randomized to one of three treatment arms (fesoterodine 4 mg, fesoterodine 8 mg or placebo) in a 1:1:1 ratio.

Reporting Groups
  Description
Placebo Subjects were treated with placebo once daily for 12 weeks.
Fesoterodine 4 mg Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Fesoterodine 8 mg Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.

Participant Flow:   Overall Study
    Placebo     Fesoterodine 4 mg     Fesoterodine 8 mg  
STARTED     318     320     313  
COMPLETED     285     286     281  
NOT COMPLETED     33     34     32  
Adverse Event                 11                 14                 14  
Lack of Efficacy                 5                 3                 2  
Lost to Follow-up                 1                 1                 0  
Withdrawal by Subject                 10                 9                 10  
Protocol Violation                 4                 3                 4  
Physician Decision                 1                 0                 0  
Pregnancy                 0                 1                 0  
Meet Withdrawal Criterion                 0                 1                 1  
Adverse Event Occured Before Treatment                 1                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Subjects were treated with placebo once daily for 12 weeks.
Fesoterodine 4 mg Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Fesoterodine 8 mg Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Fesoterodine 4 mg     Fesoterodine 8 mg     Total  
Number of Participants  
[units: participants]
  318     320     313     951  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     227     217     196     640  
>=65 years     91     103     117     311  
Age  
[units: years]
Mean ± Standard Deviation
  56.7  ± 13.5     57.2  ± 14.2     58.8  ± 13.4     57.6  ± 13.7  
Gender  
[units: participants]
       
Female     251     251     255     757  
Male     67     69     58     194  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

2.  Secondary:   Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Measure Description

Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.

Change: mean at each visit minus mean at Baseline.

Time Frame Baseline to Weeks 2, 4, 8, and 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set. No imputation was used for missing data.

Reporting Groups
  Description
Placebo Subjects were treated with placebo once daily for 12 weeks.
Fesoterodine 4 mg Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Fesoterodine 8 mg Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.

Measured Values
    Placebo     Fesoterodine 4 mg     Fesoterodine 8 mg  
Number of Participants Analyzed  
[units: participants]
  309     314     306  
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.  
[units: UUI¬†Episodes]
Mean ± Standard Deviation
     
Week 2 (n=308, 314, 305)     -0.79  ± 1.465     -1.10  ± 1.681     -1.12  ± 1.736  
Week 4 (n=301, 303, 296)     -1.15  ± 1.532     -1.48  ± 1.688     -1.49  ± 1.643  
Week 8 (n=289, 289, 287)     -1.45  ± 1.518     -1.61  ± 1.680     -1.65  ± 1.690  
Week 12 (n=284, 284, 281)     -1.49  ± 1.717     -1.76  ± 1.618     -1.87  ± 1.814  

No statistical analysis provided for Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.



3.  Secondary:   Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

4.  Secondary:   Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

5.  Secondary:   Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

6.  Secondary:   Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

7.  Secondary:   Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

8.  Secondary:   Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

9.  Secondary:   Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

10.  Secondary:   Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

11.  Secondary:   Change From Baseline in Mean Voided Volume Per Micturition at Week 12.   [ Time Frame: Baseline to Week 12 ]

12.  Secondary:   Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

13.  Secondary:   Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).   [ Time Frame: Baseline to Week12 ]

14.  Secondary:   Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.   [ Time Frame: Baseline to Week 12 ]

15.  Secondary:   Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.   [ Time Frame: Baseline to Week 12 ]

16.  Secondary:   The Number of Patients With “Severe Problems, Score 5” or “Many Severe Problems, Score 6” in Patient Perception of Bladder Condition (PPBC) at Week 12.   [ Time Frame: Baseline to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00561951     History of Changes
Other Study ID Numbers: A0221005
Study First Received: November 19, 2007
Results First Received: January 11, 2010
Last Updated: July 11, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare