A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
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
1 other identifier
interventional
789
1 country
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2006
Shorter than P25 for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 10, 2006
CompletedFirst Posted
Study publicly available on registry
July 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedResults Posted
Study results publicly available
May 10, 2010
CompletedMay 10, 2010
April 1, 2010
11 months
July 10, 2006
April 13, 2010
April 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Baseline Average Number of Daily Incontinence Episodes
Average number of daily incontinence episodes at baseline
Baseline
Change From Baseline in Average Daily Number of Incontinence Episodes
Change from Baseline to Week 12 in average daily number of incontinence episodes
Baseline to Week 12
Secondary Outcomes (4)
Baseline Average Daily Urinary Frequency
Baseline
Change From Baseline in Average Daily Urinary Frequency
Baseline to 12 weeks
Baseline Average Urine Void Volume
Baseline
Change From Baseline in Average Urine Void Volume
Change from Baseline to Week 12
Study Arms (2)
Oxybutynin topical gel
EXPERIMENTALOxybutynin topical gel
Placebo topical gel
PLACEBO COMPARATORplacebo topical gel
Interventions
1 application daily to skin for 12 weeks
1 application daily to skin for 12 weeks
Eligibility Criteria
You may qualify if:
- Females and males, 18 years of older with overactive bladder symptoms
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Homewood, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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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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Buena Park, California, United States
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Laguna Woods, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Torrance, 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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Clearwater, Florida, United States
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DeLand, Florida, United States
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Leesburg, Florida, United States
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Ocala, Florida, United States
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Plantation, Florida, United States
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Tallahassee, Florida, United States
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West Palm Beach, Florida, United States
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Alpharetta, Georgia, United States
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Atlanta, Georgia, United States
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Belville, Illinois, United States
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Chicago, Illinois, United States
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Melrose Park, Illinois, United States
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Evansville, Indiana, United States
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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
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Saint 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
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Garden City, New York, United States
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New York, New York, United States
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Williamsville, New York, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Lyndhurst, Ohio, United States
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Bethany, Oklahoma, United States
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Edmond, Oklahoma, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Newton, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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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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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Spokane, Washington, United States
Related Publications (2)
Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23.
PMID: 19233423RESULTStoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PMID: 37160401DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Hoel, PhD, Executive Director
- Organization
- Watson Laboratories, Inc
Study Officials
- STUDY DIRECTOR
Kim Caramelli, MS
Watson Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 10, 2006
First Posted
July 11, 2006
Study Start
June 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
May 10, 2010
Results First Posted
May 10, 2010
Record last verified: 2010-04