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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00350636
Recruitment Status : Completed
First Posted : July 11, 2006
Results First Posted : May 10, 2010
Last Update Posted : May 10, 2010
Information provided by:
Watson Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Oxybutynin topical gel Other: Placebo topical gel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 789 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Oxybutynin topical gel
Oxybutynin topical gel
Drug: Oxybutynin topical gel
1 application daily to skin for 12 weeks
Other Name: Oxybutynin
Placebo Comparator: Placebo topical gel
placebo topical gel
Other: Placebo topical gel
1 application daily to skin for 12 weeks
Other Name: Placebo

Primary Outcome Measures :
  1. Baseline Average Number of Daily Incontinence Episodes [ Time Frame: Baseline ]
    Average number of daily incontinence episodes at baseline

  2. Change From Baseline in Average Daily Number of Incontinence Episodes [ Time Frame: Baseline to Week 12 ]
    Change from Baseline to Week 12 in average daily number of incontinence episodes

Secondary Outcome Measures :
  1. Baseline Average Daily Urinary Frequency [ Time Frame: Baseline ]
    Number of daily urinary voids

  2. Change From Baseline in Average Daily Urinary Frequency [ Time Frame: Baseline to 12 weeks ]
    Change from baseline in average daily urinary frequency

  3. Baseline Average Urine Void Volume [ Time Frame: Baseline ]
    Baseline average urine void volume

  4. Change From Baseline in Average Urine Void Volume [ Time Frame: Change from Baseline to Week 12 ]
    Change from baseline to Week 12 in average urine void volume

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00350636

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United States, Alabama
Birmingham, Alabama, United States
Homewood, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Denver, Colorado, United States
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Waterbury, Connecticut, United States
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Aventura, Florida, United States
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Leesburg, Florida, United States
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Alpharetta, Georgia, United States
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Belville, Illinois, United States
Chicago, Illinois, United States
Melrose Park, Illinois, United States
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Evansville, Indiana, United States
South Bend, Indiana, United States
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Shreveport, Louisiana, United States
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Watertown, Massachusetts, United States
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Saginaw, Michigan, United States
St. Joseph, Michigan, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
Garden City, New York, United States
New York, New York, United States
Williamsville, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
Columbus, Ohio, United States
Lyndhurst, Ohio, United States
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Bethany, Oklahoma, United States
Edmond, Oklahoma, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
Newton, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
West Reading, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Greer, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Richmond, Virginia, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Study Director: Kim Caramelli, MS Watson Pharmaceuticals

Additional Information:
Publications of Results:
Responsible Party: Gary Hoel PhD, Executive Director, Watson Identifier: NCT00350636     History of Changes
Other Study ID Numbers: OG05009
First Posted: July 11, 2006    Key Record Dates
Results First Posted: May 10, 2010
Last Update Posted: May 10, 2010
Last Verified: April 2010

Keywords provided by Watson Pharmaceuticals:
OAB, anticholineric, oxybutynin, urge urinary incontinence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Mandelic Acids
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