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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 
Other                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 
Overall Participants Analyzed 
[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 ]

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
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Time Frame 12 weeks
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   2  

Reporting Groups
  Description
Oxybutynin Topical Gel 1 g Oxybutynin topical gel
Placebo Topical Gel 1 g placebo topical gel

Other Adverse Events
    Oxybutynin Topical Gel   Placebo Topical Gel
Total, other (not including serious) adverse events     
# participants affected / at risk   176/389 (45.24%)   145/400 (36.25%) 
Gastrointestinal disorders     
Constipation * 1     
# participants affected / at risk   7/389 (1.80%)   8/400 (2.00%) 
# events   7   9 
Diarrhea * 1     
# participants affected / at risk   9/389 (2.31%)   13/400 (3.25%) 
# events   11   13 
Dry mouth * 1     
# participants affected / at risk   29/389 (7.46%)   11/400 (2.75%) 
# events   29   12 
Gastroenteritis viral * 1     
# participants affected / at risk   8/389 (2.06%)   6/400 (1.50%) 
# events   8   6 
General disorders     
Application site pruritis * 1     
# participants affected / at risk   8/389 (2.06%)   3/400 (0.75%) 
# events   10   3 
Fatigue * 1     
# participants affected / at risk   8/389 (2.06%)   4/400 (1.00%) 
# events   8   4 
Infections and infestations     
Bronchitis * 1     
# participants affected / at risk   9/389 (2.31%)   9/400 (2.25%) 
# events   9   11 
Nasopharyngitis * 1     
# participants affected / at risk   11/389 (2.83%)   9/400 (2.25%) 
# events   11   10 
Sinusitis * 1     
# participants affected / at risk   9/389 (2.31%)   18/400 (4.50%) 
# events   10   20 
Upper respiratory tract infection * 1     
# participants affected / at risk   21/389 (5.40%)   20/400 (5.00%) 
# events   21   20 
Urinary tract infection * 1     
# participants affected / at risk   27/389 (6.94%)   17/400 (4.25%) 
# events   29   17 
Nervous system disorders     
Dizziness * 1     
# participants affected / at risk   11/389 (2.83%)   4/400 (1.00%) 
# events   12   4 
Headache * 1     
# participants affected / at risk   19/389 (4.88%)   23/400 (5.75%) 
# events   24   28 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA



  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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