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A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

Information source: Watson Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

Intervention: Oxybutynin topical gel (Drug); Placebo topical gel (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Watson Pharmaceuticals

Official(s) and/or principal investigator(s):
Kim Caramelli, MS, Study Director, Affiliation: Watson Pharmaceuticals


A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Clinical Details

Official title: Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension

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

Primary outcome:

Baseline Average Number of Daily Incontinence Episodes

Change From Baseline in Average Daily Number of Incontinence Episodes

Secondary outcome:

Baseline Average Daily Urinary Frequency

Change From Baseline in Average Daily Urinary Frequency

Baseline Average Urine Void Volume

Change From Baseline in Average Urine Void Volume


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


Inclusion Criteria:

- Females and males, 18 years of older with overactive bladder symptoms

Exclusion Criteria:

- Treatable conditions that may cause urinary incontinence

- Medical conditions in which it would be unsafe to use an anti-cholinergic agent.

- The use of concomitant drugs that would confound the efficacy evaluation.

- The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

Locations and Contacts

Birmingham, Alabama, United States

Homewood, Alabama, United States

Mobile, Alabama, United States

Montgomery, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Buena Park, California, United States

Laguna Woods, California, United States

Sacramento, California, United States

San Diego, California, United States

Torrance, California, United States

Denver, Colorado, United States

Waterbury, Connecticut, United States

Aventura, Florida, United States

Clearwater, Florida, United States

DeLand, Florida, United States

Leesburg, Florida, United States

Ocala, Florida, United States

Plantation, Florida, United States

Tallahassee, Florida, United States

West Palm Beach, Florida, United States

Alpharetta, Georgia, United States

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Chicago, Illinois, United States

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Williamsville, New York, United States

Winston-Salem, North Carolina, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Lyndhurst, Ohio, United States

Bethany, Oklahoma, United States

Edmond, Oklahoma, United States

Portland, Oregon, United States

Allentown, Pennsylvania, United States

Newton, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

West Reading, Pennsylvania, United States

Warwick, Rhode Island, United States

Greer, South Carolina, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Corpus Christi, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Richmond, Virginia, United States

Spokane, Washington, United States

Additional Information


Watson Pharma product webpage

Starting date: June 2006
Last updated: April 13, 2010

Page last updated: August 23, 2015

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