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.
Full Title of Study: “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 Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: July 2010
- 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
- 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
Arms, Groups and Cohorts
- Experimental: Oxybutynin Gel 56 mg/day
- Experimental: Oxybutynin Gel 84 mg/day
- Placebo Comparator: Placebo Gel
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Antares Pharma Inc.
- Provider of Information About this Clinical Study
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