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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:
ClinicalTrials.gov Identifier:
NCT00561951
First Posted: November 21, 2007
Last Update Posted: July 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
Results First Submitted: January 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Overactive Bladder
Interventions: Drug: fesoterodine fumarate
Drug: Placebo

  Participant Flow


  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.
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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 
Overall Participants Analyzed 
[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
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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
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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
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