Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
NCT01192568 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxybutynin
Study Locations (10)
California
- Loma Linda University /ID# 236889 — Loma Linda
- Child Hosp of Orange County,CA /ID# 237517 — Orange
Colorado
- Children's Hospital Colorado - Aurora /ID# 237620 — Aurora
Georgia
- Augusta University Medical Center /ID# 238188 — Augusta
Mississippi
- University of Mississippi Medical Center /ID# 238065 — Jackson
New York
- Albany Medical College /ID# 236880 — Albany
North Carolina
- Duke University /ID# 237494 — Durham
Oregon
- Duplicate_Oregon Health & Science University /ID# 234354 — Portland
Texas
- Cook Children's Med. Center /ID# 237538 — Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2011-05-17 |
| Est. Completion | 2023-10-24 |
| Phase | Phase 4 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01192568
The ClinicalTrials.gov registry entry for NCT01192568 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Neurogenic Bladder appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01192568 reports 10 study locations spanning 9 distinct geographic areas — top geographies include California, Colorado, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01192568 about?
NCT01192568 is a clinical study titled "Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder". 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 pot...
What is the current status of trial NCT01192568?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2011-05-17. Estimated completion is 2023-10-24.
What conditions does trial NCT01192568 study?
This clinical trial studies the following conditions: Neurogenic Bladder, Overactive Detrusor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01192568?
The interventions under investigation include: Placebo (DRUG), Oxybutynin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01192568?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01192568 being conducted?
This trial has 10 study locations across California, Colorado, Georgia, Mississippi, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.