Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
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
1 other identifier
interventional
626
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2009
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 25, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
January 19, 2011
CompletedJuly 2, 2014
June 1, 2014
1.3 years
May 25, 2009
November 29, 2010
June 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
12 weeks
Study Arms (3)
Oxybutynin Gel 56 mg/day
EXPERIMENTALOxybutynin Gel 84 mg/day
EXPERIMENTALPlacebo Gel
PLACEBO COMPARATORInterventions
Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo
Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Little Rock, Arkansas, 72211, United States
Unknown Facility
Laguna Hills, California, 92653, United States
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92120, United States
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Farmington, Connecticut, 06032, United States
Unknown Facility
New Britain, Connecticut, 06052, United States
Unknown Facility
New Port Richey, Florida, 34625, United States
Unknown Facility
North Miami, Florida, 33161, United States
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Pembroke Pines, Florida, 33024, United States
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Sarasota, Florida, 34232, United States
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St. Petersburg, Florida, 33710, United States
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Tampa, Florida, 33607, United States
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Wellington, Florida, 33414, United States
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Columbus, Georgia, 31904, United States
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Sandy Springs, Georgia, 30328, United States
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Stockbridge, Georgia, 30281, United States
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Evanston, Illinois, 60201, United States
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West Des Moines, Iowa, 50266, United States
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Shreveport, Louisiana, 71106, United States
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Annapolis, Maryland, 21401, United States
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Towson, Maryland, 21204, United States
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Watertown, Massachusetts, 02472, United States
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Grand Rapids, Michigan, 49503, United States
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Saginaw, Michigan, 48604, United States
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Chesterfield, Missouri, 63017, United States
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Las Vegas, Nevada, 89130, United States
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Brooklyn, New York, 11211, United States
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Endwell, New York, 13760, United States
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Kingston, New York, 12401, United States
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Poughkeepsie, New York, 12601, United States
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Williamsville, New York, 14221, United States
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Cary, North Carolina, 27518, United States
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Charlotte, North Carolina, 28209, United States
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Harrisburg, North Carolina, 28075, United States
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Raleigh, North Carolina, 27607, United States
Unknown Facility
Raleigh, North Carolina, 27609, United States
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Salisbury, North Carolina, 28144, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Wadsworth, Ohio, 44218, United States
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Bethany, Oklahoma, 73008, United States
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Corvallis, Oregon, 97330, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Landsdale, Pennsylvania, 19446, United States
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Greenville, South Carolina, 29615, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Myrtle Beach, South Carolina, 29572, United States
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Sioux Falls, South Dakota, 57104, United States
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Fayetteville, Tennessee, 37334, United States
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Provo, Utah, 84604, United States
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Richmond, Virginia, 23294, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Spokane, Washington, 99207, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kaushik Dave
- Organization
- Antares Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2009
First Posted
May 27, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2010
Study Completion
November 1, 2010
Last Updated
July 2, 2014
Results First Posted
January 19, 2011
Record last verified: 2014-06