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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.

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.


Condition or disease Intervention/treatment Phase
Urge Urinary Incontinence Urinary Frequency Drug: Oxybutynin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 626 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Oxybutynin Gel 56 mg/day 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%
Experimental: Oxybutynin Gel 84 mg/day 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%
Placebo Comparator: Placebo Gel 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%



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909181


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Sponsors and Collaborators
Antares Pharma Inc.

Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT00909181     History of Changes
Other Study ID Numbers: 20070060
First Posted: May 27, 2009    Key Record Dates
Results First Posted: January 19, 2011
Last Update Posted: July 2, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Oxybutynin
Mandelic Acids
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents