Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder

Study Identifier
OG09002
CT.gov Identifier
NCT01192568
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
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Study Details

Medical Condition
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • Oxybutynin
  • Placebo
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    3 - 16 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 3 years to \< 17 years * Neurogenic bladder * Neurological condition * CIC
    Exclusion Criteria:
    * Have anatomical bladder abnormalities * Sensitivity to anticholinergics * Bladder augmentation

    Protocol Summary

    This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.

    Study Locations

    Location
    Status
    Location
    Loma Linda University /ID# 236889
    Loma Linda, California, United States, 92354
    Status
    Not applicable
    Location
    Child Hosp of Orange County,CA /ID# 237517
    Orange, California, United States, 92868
    Status
    Not applicable
    Location
    Children's Hospital Colorado - Aurora /ID# 237620
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Augusta University Medical Center /ID# 238188
    Augusta, Georgia, United States, 30912-0004
    Status
    Not applicable
    Location
    University of Mississippi Medical Center /ID# 238065
    Jackson, Mississippi, United States, 39216-4500
    Status
    Not applicable
    Location
    Albany Medical College /ID# 236880
    Albany, New York, United States, 12208
    Status
    Not applicable
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