A Study Evaluating the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients

About this Study

This study will evaluate the effectiveness, safety and skin tolerance of oxybutynin chloride get compared to placebo in pediatric patients during the first 6 weeks of a 14 week open-label treatment period.

Sponsor Protocol ID:OG09002
IRB Number:2017-0099
Actively Enrolling
Observational
Phase 4
May 28, 2019
Eligibility Criteria
3 years old
17 years old
Both Male and Female
No
Yes
No

Inclusion Criteria
  • 3 years-of-age (6 years for Pre-Amendment 3) to 17 years-of-age
  • Have a diagnosis of detrusor overactivity associated with a neurological condition. 
  • Are capable of completing the urinary diary with or without assistance from a parent or guardian. 
  • Have correctly completed the baseline urinary diary. 
  • Are capable of understanding and complying with the study requirements, are willing to provide assent to participate in the study as required by the institutional review board or ethics committee, and the parent(s) or legal guardian(s) have been adequately informed and have signed the informed consent/authorization to disclose PHI. 


Exclusion Criteria
  • Are pregnant or lactating. 
  • Have had surgical bladder augmentation. 
  • Have any anatomical abnormalities of the urinary tract system that can affect bladder function. 
  • Have an active skin disorder, such as eczema, seborrhea, or psoriasis affecting the gel application areas. 
  •  Have a known hypersensitivity or other contraindication to anticholinergic medications. 
  • Have participated in another investigational drug study within 30 days prior to the Baseline Visit. 
  • Have been diagnosed with asymmetric/unequal or severe refractive error in either eye prior to the Baseline Visit.


Categories Click category to view its trials.
Neurosciences
Pediatrics
Participating Locations
Children’s of Mississippi Hospital - Blair E. Batson Tower
Contact Information
Contact Name: Cathy Hudgins
Phone Number: 601-815-9276
Email: chudgins@umc.edu
Principal Investigator:Bean, Christopher M, M.D.
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