Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01042236
First received: January 4, 2010
Last updated: July 20, 2011
Last verified: July 2011
Results First Received: June 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Stress Urinary Incontinence
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants randomized to receive sequenced dosing of Fesoterodine 4 milligrams (mg) (A), or Fesoterodine 8 milligrams (B), or Placebo matching study treatment (C). Each dosed for 7 days with a 7 day washout between dosing periods. Dosing sequenced as ABC, ACB, BAC, BCA, CAB, or CBA.

Reporting Groups
  Description
Sequence ABC Fesoterodine 4 mg (A) tablet administered by mouth (PO) once daily (OD) for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then placebo matching study treatment (C) with 7 day washout between dosing periods.
Sequence BCA Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
Sequence CAB Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
Sequence ACB Fesoterodine 4 mg (A) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
Sequence BAC Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then placebo matching study treatment (C) with 7 day washout between dosing periods.
Sequence CBA Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.

Participant Flow for 3 periods

Period 1:   Treatment Period 1
    Sequence ABC     Sequence BCA     Sequence CAB     Sequence ACB     Sequence BAC     Sequence CBA  
STARTED     3     4     3     5     4     3  
COMPLETED     3     3     3     5     3     3  
NOT COMPLETED     0     1     0     0     1     0  
Adverse Event                 0                 1                 0                 0                 1                 0  

Period 2:   Treatment Period 2
    Sequence ABC     Sequence BCA     Sequence CAB     Sequence ACB     Sequence BAC     Sequence CBA  
STARTED     3     3     3     5     3     3  
COMPLETED     3     3     3     5     3     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Treatment Period 3
    Sequence ABC     Sequence BCA     Sequence CAB     Sequence ACB     Sequence BAC     Sequence CBA  
STARTED     3     3     3     5     3     3  
COMPLETED     3     3     3     3     3     3  
NOT COMPLETED     0     0     0     2     0     0  
Adverse Event                 0                 0                 0                 1                 0                 0  
Protocol Violation                 0                 0                 0                 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
Entire Study Population Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) first, and Placebo first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  22  
Age  
[units: Years]
Mean ± Standard Deviation
  47.9  ± 8.4  
Gender  
[units: Participants]
 
Female     22  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Opening Urethral Pressure (OUP) at Day 7   [ Time Frame: Baseline, Day 7 of each period ]

2.  Secondary:   Change From Baseline in Closing Urethral Pressure at Day 7   [ Time Frame: Baseline, Day 7 of each period ]

3.  Secondary:   Change From Baseline in Opening Urethral Elastance at Day 7   [ Time Frame: Baseline, Day 7 of each period ]

4.  Secondary:   Change From Baseline in Closing Urethral Elastance at Day 7   [ Time Frame: Baseline, Day 7 of each period ]

5.  Secondary:   Incontinence Episode Frequency Per 24 Hours   [ Time Frame: Baseline, Day 7 of each period ]

6.  Secondary:   Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours   [ Time Frame: Baseline, Day 7 of each period ]

7.  Secondary:   Stress Incontinence Episode Frequency Per 24 Hours   [ Time Frame: Baseline, Day 7 of each period ]

8.  Secondary:   Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours   [ Time Frame: Baseline, Day 7 of each period ]

9.  Secondary:   Urgency Urinary Incontinence Episode Frequency Per 24 Hours   [ Time Frame: Baseline, Day 7 of each period ]

10.  Secondary:   Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours   [ Time Frame: Baseline, Day 7 of each period ]

11.  Secondary:   Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration   [ Time Frame: Baseline, Day 7 of each period ]


  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
No text entered.


  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: NCT01042236     History of Changes
Other Study ID Numbers: A0221064
Study First Received: January 4, 2010
Results First Received: June 8, 2011
Last Updated: July 20, 2011
Health Authority: Denmark: Danish Medical Authority