A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

This study has been completed.
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00350636
First received: July 10, 2006
Last updated: April 13, 2010
Last verified: April 2010
Results First Received: April 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Overactive Bladder
Interventions: Drug: Oxybutynin topical gel
Other: Placebo topical gel

  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
Oxybutynin Topical Gel 1 g Oxybutynin topical gel
Placebo Topical Gel 1 g placebo topical gel

Participant Flow:   Overall Study
    Oxybutynin Topical Gel     Placebo Topical Gel  
STARTED     389     400  
COMPLETED     346     355  
NOT COMPLETED     43     45  
Adverse Event                 19                 13  
Protocol Violation                 1                 3  
Withdrawal by Subject                 13                 17  
Lost to Follow-up                 9                 8  
Physician Decision                 0                 2  
Unknown                 1                 2  



  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
Oxybutynin Topical Gel 1 g Oxybutynin topical gel
Placebo Topical Gel 1 g placebo topical gel
Total Total of all reporting groups

Baseline Measures
    Oxybutynin Topical Gel     Placebo Topical Gel     Total  
Number of Participants  
[units: participants]
  389     400     789  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     246     260     506  
>=65 years     143     140     283  
Age  
[units: years]
Mean ± Standard Deviation
  59.5  ± 12.50     59.3  ± 12.17     59.4  ± 12.17  
Gender  
[units: participants]
     
Female     352     352     704  
Male     37     48     85  
Region of Enrollment  
[units: participants]
     
United States     389     400     789  



  Outcome Measures
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1.  Primary:   Baseline Average Number of Daily Incontinence Episodes   [ Time Frame: Baseline ]

2.  Primary:   Change From Baseline in Average Daily Number of Incontinence Episodes   [ Time Frame: Baseline to Week 12 ]
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Measure Type Primary
Measure Title Change From Baseline in Average Daily Number of Incontinence Episodes
Measure Description Change from Baseline to Week 12 in average daily number of incontinence episodes
Time Frame Baseline to Week 12  
Safety Issue No  

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
Oxybutynin Topical Gel 1 g Oxybutynin topical gel
Placebo Topical Gel 1 g placebo topical gel

Measured Values
    Oxybutynin Topical Gel     Placebo Topical Gel  
Number of Participants Analyzed  
[units: participants]
  389     400  
Change From Baseline in Average Daily Number of Incontinence Episodes  
[units: Number of episodes]
Mean ± Standard Deviation
  -3.0  ± 2.73     -2.5  ± 3.06  

No statistical analysis provided for Change From Baseline in Average Daily Number of Incontinence Episodes



3.  Secondary:   Baseline Average Daily Urinary Frequency   [ Time Frame: Baseline ]

4.  Secondary:   Change From Baseline in Average Daily Urinary Frequency   [ Time Frame: Baseline to 12 weeks ]

5.  Secondary:   Baseline Average Urine Void Volume   [ Time Frame: Baseline ]

6.  Secondary:   Change From Baseline in Average Urine Void Volume   [ Time Frame: Change from 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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  More Information