Phase 4
N=33
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
Overactive Detrusor · Neurogenic Bladder
Bottom Line
View on ClinicalTrials.gov: NCT01192568 ↗Enrolled (actual)
33
Serious AEs
7.1%
Results posted
Sep 2024
Primary outcome: Primary: Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6 — -0.45; 16.91; 13.82; 15.32 percentage of point — p=0.0928
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxybutynin (Drug); Placebo (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6 |
-0.45; 16.91; 13.82; 15.32 | 0.0928 |
| SECONDARY Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6 |
-24.59; 14.33 | 0.0054 sig |
| SECONDARY Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6 |
-12.03; 14.18; 29.78; 22.20 | 0.1739 |
| SECONDARY Change From Baseline in Average Number of Catheterizations Per Day at Week 6 |
0.19; -0.03; -0.67; -0.36 | 0.2660 |
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.
Eligibility Criteria
Inclusion Criteria
- 3 years to < 17 years
- Neurogenic bladder
- Neurological condition
- CIC
Exclusion Criteria
- Have anatomical bladder abnormalities
- Sensitivity to anticholinergics
- Bladder augmentation
Data sourced from ClinicalTrials.gov (NCT01192568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.