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
  Hide Participant Flow

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
No text entered.

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
  Hide Baseline Characteristics

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
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
  Show All Outcome Measures

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
  Hide Other Adverse Events

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     145/400  
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



  More Information
  Hide More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Gary Hoel, PhD, Executive Director
Organization: Watson Laboratories, Inc
phone: 801-808-8866
e-mail: gary.hoel@watson.com


Publications of Results:

Responsible Party: Gary Hoel PhD, Executive Director, Watson
ClinicalTrials.gov Identifier: NCT00350636     History of Changes
Other Study ID Numbers: OG05009
Study First Received: July 10, 2006
Results First Received: April 13, 2010
Last Updated: April 13, 2010
Health Authority: United States: Food and Drug Administration