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


  Baseline Characteristics
  Hide Baseline Characteristics

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 ]

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


  Limitations and Caveats
  Hide 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.


  More Information