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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.

Tracking Information
First Submitted Date  ICMJE May 25, 2009
First Posted Date  ICMJE May 27, 2009
Results First Submitted Date  ICMJE November 29, 2010
Results First Posted Date  ICMJE January 19, 2011
Last Update Posted Date July 2, 2014
Study Start Date  ICMJE March 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 [ Time Frame: 12 weeks ]
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2009)
Change from baseline to Week 12 in the number of urinary incontinence episodes (UIE) per week [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2009)
Change from baseline to Week 12 in the average daily urinary frequency [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
Official Title  ICMJE A Double-Blind, Randomized, Parallel, Placebo-Controlled, Multicenter Study Evaluating the Effect of Treatment With Topically Administered Oxybutynin Gel in Patients With Urinary Frequency, and Urge and Mixed Urinary Incontinence With a Predominance of Urge Incontinence Episodes With an Open-Label Extension
Brief Summary

The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel.

The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Urge Urinary Incontinence
  • Urinary Frequency
Intervention  ICMJE
  • Drug: Oxybutynin

    Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment.

    Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo

    Other Name: Anturol; Oxybutynin Gel 3%
  • Drug: Placebo

    Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment.

    Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo

    Other Name: Anturol; Oxybutynin Gel 3%
Study Arms  ICMJE
  • Experimental: Oxybutynin Gel 56 mg/day
    Interventions:
    • Drug: Oxybutynin
    • Drug: Placebo
  • Experimental: Oxybutynin Gel 84 mg/day
    Interventions:
    • Drug: Oxybutynin
    • Drug: Placebo
  • Placebo Comparator: Placebo Gel
    Interventions:
    • Drug: Oxybutynin
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2010)
626
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2009)
600
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months
  • Have a history of at least 1 - 2 urge episodes and 8 or more voids per day

Exclusion Criteria:

  • Incontinence that is predominantly stress, insensate, or overflow in nature, or incontinence related to chronic illness, anatomical weakness/abnormalities or concomitant medications
  • PVR volume > 200 mL or relative PVR > 50% of pre-void volume as determined by bladder ultrasound
  • History of urinary retention, gastric retention, or uncontrollable narrow-angle glaucoma, or patients who are at risk for these conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00909181
Other Study ID Numbers  ICMJE 20070060
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antares Pharma Inc.
Study Sponsor  ICMJE Antares Pharma Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Antares Pharma Inc.
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP