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Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

Information source: Antares Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urge Urinary Incontinence; Urinary Frequency

Intervention: Oxybutynin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Antares Pharma Inc.


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- History of urinary retention, gastric retention, or uncontrollable narrow-angle

glaucoma, or patients who are at risk for these conditions

Locations and Contacts

Birmingham, Alabama 35233, United States

Little Rock, Arkansas 72211, United States

Laguna Hills, California 92653, United States

Los Angeles, California 90048, United States

San Diego, California 92120, United States

San Diego, California 92103, United States

Farmington, Connecticut 06032, United States

New Britain, Connecticut 06052, United States

N. Miami, Florida 33161, United States

New Port Richey, Florida 34625, United States

Pembroke Pines, Florida 33024, United States

Sarasota, Florida 34232, United States

St. Petersburg, Florida 33710, United States

Tampa, Florida 33607, United States

Wellington, Florida 33414, United States

Columbus, Georgia 31904, United States

Sandy Springs, Georgia 30328, United States

Stockbridge, Georgia 30281, United States

Evanston, Illinois 60201, United States

West Des Moines, Iowa 50266, United States

Shreveport, Louisiana 71106, United States

Annapolis, Maryland 21401, United States

Towson, Maryland 21204, United States

Watertown, Massachusetts 02472, United States

Grand Rapids, Michigan 49503, United States

Saginaw, Michigan 48604, United States

Chesterfield, Missouri 63017, United States

Las Vegas, Nevada 89130, United States

Brooklyn, New York 11211, United States

Endwell, New York 13760, United States

Kingston, New York 12401, United States

Poughkeepsie, New York 12601, United States

Williamsville, New York 14221, United States

Cary, North Carolina 27518, United States

Charlotte, North Carolina 28209, United States

Harrisburg, North Carolina 28075, United States

Raleigh, North Carolina 27607, United States

Raleigh, North Carolina 27609, United States

Salisbury, North Carolina 28144, United States

Wilmington, North Carolina 28401, United States

Winston-Salem, North Carolina 27103, United States

Wadsworth, Ohio 44218, United States

Bethany, Oklahoma 73008, United States

Corvallis, Oregon 97330, United States

Bala Cynwyd, Pennsylvania 19004, United States

Landsdale, Pennsylvania 19446, United States

Greenville, South Carolina 29615, United States

Mount Pleasant, South Carolina 29464, United States

Myrtle Beach, South Carolina 29572, United States

Sioux Falls, South Dakota 57104, United States

Fayetteville, Tennessee 37334, United States

Provo, Utah 84604, United States

Richmond, Virginia 23294, United States

Seattle, Washington 98104, United States

Spokane, Washington 99207, United States

Additional Information

Starting date: March 2009
Last updated: June 23, 2014

Page last updated: August 23, 2015

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