Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01054222
First received: January 20, 2010
Last updated: April 2, 2013
Last verified: February 2013
Results First Received: December 17, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Urinary Bladder, Overactive
Intervention: Drug: Fesoterodine

  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
Participants who completed treatment in study A0221045 (NCT00798434) were included in this study as per investigator's discretion.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fesoterodine Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).

Participant Flow:   Overall Study
    Fesoterodine  
STARTED     31  
COMPLETED     20  
NOT COMPLETED     11  
Lack of Efficacy                 1  
Lost to Follow-up                 4  
Withdrawal by Subject                 6  



  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
Fesoterodine Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).

Baseline Measures
    Fesoterodine  
Number of Participants  
[units: participants]
  31  
Age  
[units: Years]
Mean ± Standard Deviation
  75.4  ± 6.0  
Gender  
[units: Participants]
 
Female     30  
Male     1  



  Outcome Measures
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1.  Primary:   Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])   [ Time Frame: End of Treatment (up to Week 82) ]

2.  Secondary:   Mean Number of Micturition-Related Urgency Episodes Per 24 Hours   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18 ]

3.  Secondary:   Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

4.  Secondary:   Mean Number of Micturitions Per 24 Hours   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

5.  Secondary:   Mean Number of Nocturnal Micturitions Per 24 Hours   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

6.  Secondary:   Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

7.  Secondary:   Daily Sum Rating on the Urinary Sensation Scale (USS)   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

8.  Secondary:   Percentage of Incontinent Participants at Baseline   [ Time Frame: Baseline ]

9.  Secondary:   Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode   [ Time Frame: Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

10.  Secondary:   Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

11.  Secondary:   Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

12.  Secondary:   Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

13.  Secondary:   Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

14.  Secondary:   Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

15.  Secondary:   Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)   [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82) ]

16.  Secondary:   King’s Health Questionnaire (KHQ) Domain Scores   [ Time Frame: Baseline, End of Treatment (EOT) (Week 82) ]


  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
Due to the small sample size and that this is a single country study (Portugal) the results should be interpreted with caution.  


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: NCT01054222     History of Changes
Other Study ID Numbers: A0221090
Study First Received: January 20, 2010
Results First Received: December 17, 2012
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration