Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00658684
First received: April 9, 2008
Last updated: October 5, 2010
Last verified: October 2010
Results First Received: July 14, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Overactive Bladder
Intervention: Drug: fesoterodine fumarate

  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
Subjects were screened at 12 centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After screening, eligible subjects entered a run-in phase during which they completed a 3-day micturition diary for 3 consecutive days in 7 days prior to Baseline visit. At Baseline visit, the diary data and screening laboratory data were checked against the entry criteria to identify subjects eligible for study participation.

Reporting Groups
  Description
Total All subjects
4 mg Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
4 mg > 8 mg > 4 mg Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
4 mg > 8 mg Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)

Participant Flow:   Overall Study
    Total     4 mg     4 mg > 8 mg > 4 mg     4 mg > 8 mg  
STARTED     152     99     25     28  
COMPLETED     133     84     22     27  
NOT COMPLETED     19     15     3     1  
Adverse Event                 10                 8                 2                 0  
Withdrawal by Subject                 6                 4                 1                 1  
Lack of Efficacy                 1                 1                 0                 0  
Protocol Violation                 1                 1                 0                 0  
Pregnancy                 1                 1                 0                 0  



  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
4 mg Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
4 mg > 8 mg > 4 mg Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
4 mg > 8 mg Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Total Total of all reporting groups

Baseline Measures
    4 mg     4 mg > 8 mg > 4 mg     4 mg > 8 mg     Total  
Number of Participants  
[units: participants]
  99     25     28     152  
Age  
[units: years]
Mean ± Standard Deviation
  51.0  ± 13.1     54.7  ± 10.5     57.0  ± 11.7     52.7  ± 12.6  
Gender  
[units: Number¬†of¬†subjects]
       
Female     88     21     24     133  
Male     11     4     4     19  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume   [ Time Frame: 52 Weeks ]

2.  Secondary:   Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52   [ Time Frame: Week 4, 8, 28 and 52 ]

3.  Secondary:   Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52   [ Time Frame: Week 4, 8, 28 and 52 ]

4.  Secondary:   Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52   [ Time Frame: Week 4, 8, 28 and 52 ]

5.  Secondary:   Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52   [ Time Frame: Week 4, 8, 28 and 52 ]

6.  Secondary:   Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52   [ Time Frame: Week 4, 8, 28 and 52 ]

7.  Secondary:   Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52   [ Time Frame: Week 4, 8, 28 and 52 ]

8.  Secondary:   Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52   [ Time Frame: Week 28 and 52 ]

9.  Secondary:   Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52   [ Time Frame: Week 28 and 52 ]

10.  Secondary:   The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage   [ Time Frame: Week 28 and 52 ]

11.  Secondary:   Change From Baseline in Grade of PPBC at Week 28 and 52   [ Time Frame: Week 28 and 52 ]


  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: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00658684     History of Changes
Other Study ID Numbers: A0221006, A0221006
Study First Received: April 9, 2008
Results First Received: July 14, 2010
Last Updated: October 5, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare