Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
Public ClinicalTrials.gov record NCT01192568. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Two-part, Multicenter, Dose-titration 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01192568
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 52 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 17, 2011 (Actual)
- Primary completion
- Aug 29, 2023 (Actual)
- Completion
- Oct 24, 2023 (Actual)
- Last update posted
- Sep 4, 2024
2011 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University /ID# 236889 | Loma Linda | California | 92354 | — |
| Child Hosp of Orange County,CA /ID# 237517 | Orange | California | 92868 | — |
| Children's Hospital Colorado - Aurora /ID# 237620 | Aurora | Colorado | 80045 | — |
| Augusta University Medical Center /ID# 238188 | Augusta | Georgia | 30912-0004 | — |
| University of Mississippi Medical Center /ID# 238065 | Jackson | Mississippi | 39216-4500 | — |
| Albany Medical College /ID# 236880 | Albany | New York | 12208 | — |
| Duke University /ID# 237494 | Durham | North Carolina | 27710 | — |
| Duplicate_Oregon Health & Science University /ID# 234354 | Portland | Oregon | 97239-3011 | — |
| Cook Children's Med. Center /ID# 237538 | Fort Worth | Texas | 76104 | — |
| Child Hosp of the King's Dtr's /ID# 237799 | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01192568, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 4, 2024 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01192568 live on ClinicalTrials.gov.