A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00928070
First received: June 24, 2009
Last updated: December 10, 2012
Last verified: December 2012
Results First Received: December 10, 2012  
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
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
Fesoterodine Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.

Participant Flow:   Overall Study
    Placebo     Fesoterodine  
STARTED     283     283  
Treated     281     281  
COMPLETED     220     226  
NOT COMPLETED     63     57  
Lost to Follow-up                 1                 2  
Withdrawal by Subject                 10                 3  
Adverse Event                 14                 26  
Lack of Efficacy                 9                 5  
Did not meet entrance criteria                 16                 9  
Protocol Violation                 6                 5  
Randomized but not treated                 2                 2  
Unspecified                 5                 5  



  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 Participants who received placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
Fesoterodine Participants who received fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Fesoterodine     Total  
Number of Participants  
[units: participants]
  281     281     562  
Age, Customized  
[units: participants]
     
65 to 74 years     134     145     279  
75 to 84 years     118     106     224  
At least 85 years     29     30     59  
Gender  
[units: participants]
     
Female     236     225     461  
Male     45     56     101  



  Outcome Measures
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1.  Primary:   Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours   [ Time Frame: Baseline ]

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

3.  Secondary:   Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4   [ Time Frame: Baseline, Week 4 ]

4.  Secondary:   Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

5.  Secondary:   Mean Number of Micturitions Per 24 Hours   [ Time Frame: Baseline ]

6.  Secondary:   Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

7.  Secondary:   Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

8.  Secondary:   Mean Number of Micturition-related Urgency Episodes Per 24 Hours   [ Time Frame: Baseline ]

9.  Secondary:   Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

10.  Secondary:   Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

11.  Secondary:   Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours   [ Time Frame: Baseline ]

12.  Secondary:   Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

13.  Secondary:   Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

14.  Secondary:   Frequency-Urgency Sum Rating Per 24 Hours   [ Time Frame: Baseline ]

15.  Secondary:   Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

16.  Secondary:   Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

17.  Secondary:   Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12   [ Time Frame: Screening, Week 4, 12 ]

18.  Secondary:   Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score   [ Time Frame: Baseline ]

19.  Secondary:   Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

20.  Secondary:   Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)   [ Time Frame: Baseline ]

21.  Secondary:   Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12   [ Time Frame: Baseline, Week 4, 12 ]

22.  Secondary:   Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control   [ Time Frame: Week 12 ]

23.  Secondary:   Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response   [ Time Frame: Week 12 ]

24.  Secondary:   Mini Mental State Examination (MMSE)   [ Time Frame: Screening ]

25.  Secondary:   Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12   [ Time Frame: Screening, Week 12 ]

26.  Secondary:   Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12   [ Time Frame: Baseline, Week 4, 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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  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.


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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00928070     History of Changes
Other Study ID Numbers: A0221049
Study First Received: June 24, 2009
Results First Received: December 10, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration