Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

Phase 3

Completed

• Conditions: Urge Urinary Incontinence; Urinary Frequency
• Interventions: Drug: Oxybutynin; Drug: Placebo

• Registration Number: NCT00909181
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-05-25
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2010-07
• Study Completion: 2010-11
• Results First Submitted: 2010-11-29
• Results First Submitted QC: 2010-12-16
• Results First Posted: 2011-01-19
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 626

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxybutynin Gel 56 mg/day	Placebo	-
Oxybutynin Gel 84 mg/day	Placebo	-
Placebo Gel	Placebo	-
Oxybutynin Gel 56 mg/day	Oxybutynin	-
Oxybutynin Gel 84 mg/day	Oxybutynin	-
Placebo Gel	Oxybutynin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12	12 weeks	Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.