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Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

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ClinicalTrials.gov Identifier: NCT00909181
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : January 19, 2011
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Urge Urinary Incontinence
Urinary Frequency
Interventions Drug: Oxybutynin
Drug: Placebo
Enrollment 626
Recruitment Details Recruitment in clinical sites (urologists mainly) started in September 2007 and was terminated in February 2010.
Pre-assignment Details Baseline period was 1 week. Patients on OAB drugs had to wash out.
Arm/Group Title Oxybutynin Gel 56 mg/Day Oxybutynin Gel 84 mg/Day Placebo Gel
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 210 214 202
Completed 171 196 169
Not Completed 39 18 33
Reason Not Completed
Lost to Follow-up             39             18             33
Arm/Group Title Oxybutynin Gel 56 mg/Day Oxybutynin Gel 84 mg/Day Placebo Gel Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 210 214 202 626
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 214 participants 202 participants 626 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
120
  57.1%
122
  57.0%
120
  59.4%
362
  57.8%
>=65 years
90
  42.9%
92
  43.0%
82
  40.6%
264
  42.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 210 participants 214 participants 202 participants 626 participants
59.4  (12.6) 59.1  (13.3) 57.8  (13.3) 58.8  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 214 participants 202 participants 626 participants
Female
182
  86.7%
182
  85.0%
178
  88.1%
542
  86.6%
Male
28
  13.3%
32
  15.0%
24
  11.9%
84
  13.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 210 participants 214 participants 202 participants 626 participants
210 214 202 626
Number of incontinent episodes at baseline  
Mean (Standard Deviation)
Unit of measure:  Episodes
Number Analyzed 210 participants 214 participants 202 participants 626 participants
50.1  (32.5) 43.6  (27.5) 45.8  (28.9) 46.5  (29.3)
1.Primary Outcome
Title Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
Hide Description Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment
Arm/Group Title Oxybutynin Gel 56 mg/Day Oxybutynin Gel 84 mg/Day Placebo Gel
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 175 191 166
Mean (Standard Deviation)
Unit of Measure: Episodes
-24.8  (28.7) -21.9  (25.1) -20.0  (27.0)
Time Frame Throughout whole study (20 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxybutynin Gel 56 mg/Day Oxybutynin Gel 84 mg/Day Placebo Gel
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Oxybutynin Gel 56 mg/Day Oxybutynin Gel 84 mg/Day Placebo Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Oxybutynin Gel 56 mg/Day Oxybutynin Gel 84 mg/Day Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/210 (1.43%)      4/214 (1.87%)      2/202 (0.99%)    
Blood and lymphatic system disorders       
Sickle cell anaemia with crisis  1  0/210 (0.00%)  0 0/214 (0.00%)  0 1/202 (0.50%)  1
Cardiac disorders       
Angina pectoris  1  1/210 (0.48%)  1 0/214 (0.00%)  0 0/202 (0.00%)  0
Hepatobiliary disorders       
Hepatic neoplasm malignant  1  1/210 (0.48%)  1 0/214 (0.00%)  0 0/202 (0.00%)  0
Injury, poisoning and procedural complications       
Fibula fracture  1  0/210 (0.00%)  0 1/214 (0.47%)  1 0/202 (0.00%)  0
Meniscus lesion  1  0/210 (0.00%)  0 1/214 (0.47%)  1 0/202 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Abdominal pain  1  1/210 (0.48%)  1 0/214 (0.00%)  0 0/202 (0.00%)  0
Chest pain  1  0/210 (0.00%)  0 1/214 (0.47%)  1 0/202 (0.00%)  0
Reproductive system and breast disorders       
Abortion missed  1  0/210 (0.00%)  0 1/214 (0.47%)  1 0/202 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonia  1  0/210 (0.00%)  0 1/214 (0.47%)  1 2/202 (0.99%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Oxybutynin Gel 56 mg/Day Oxybutynin Gel 84 mg/Day Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/210 (46.67%)      90/214 (42.06%)      53/202 (26.24%)    
Gastrointestinal disorders       
Dry mouth  1  23/210 (10.95%)  26/214 (12.15%)  10/202 (4.95%) 
Constipation  1  3/210 (1.43%)  8/214 (3.74%)  5/202 (2.48%) 
Diarrhoe  1  5/210 (2.38%)  2/214 (0.93%)  1/202 (0.50%) 
General disorders       
Application site erythema  1  8/210 (3.81%)  8/214 (3.74%)  2/202 (0.99%) 
Application site rash  1  9/210 (4.29%)  7/214 (3.27%)  1/202 (0.50%) 
Application site pruritus  1  3/210 (1.43%)  6/214 (2.80%)  1/202 (0.50%) 
Infections and infestations       
Urinary tract infection  1  9/210 (4.29%)  6/214 (2.80%)  4/202 (1.98%) 
Nasopharyngitis  1  5/210 (2.38%)  5/214 (2.34%)  0/202 (0.00%) 
Sinusitis  1  5/210 (2.38%)  3/214 (1.40%)  2/202 (0.99%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  5/210 (2.38%)  2/214 (0.93%)  5/202 (2.48%) 
Nervous system disorders       
Headache  1  6/210 (2.86%)  6/214 (2.80%)  8/202 (3.96%) 
Dizziness  1  6/210 (2.86%)  2/214 (0.93%)  4/202 (1.98%) 
Respiratory, thoracic and mediastinal disorders       
Upper respiratory tract infection  1  6/210 (2.86%)  6/214 (2.80%)  10/202 (4.95%) 
Skin and subcutaneous tissue disorders       
Application site reaction  1  5/210 (2.38%)  3/214 (1.40%)  0/202 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kaushik Dave
Organization: Antares Pharma
Phone: 609 359 3020
EMail: kdave@antarespharma.com
Layout table for additonal information
Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT00909181    
Other Study ID Numbers: 20070060
First Submitted: May 25, 2009
First Posted: May 27, 2009
Results First Submitted: November 29, 2010
Results First Posted: January 19, 2011
Last Update Posted: July 2, 2014