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NCT01192568 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
A Phase 4 study of Neurogenic Bladder and Overactive Detrusor, sponsored by AbbVie.
- Completed
- Registry status
- Phase 4
- Development phase
- 52
- Enrollment target
- 10
- Study locations
NCT01192568: Completed Phase 4 study of Neurogenic Bladder and Overactive Detrusor, sponsored by AbbVie.
NCT01192568 is a Phase 4 study of Neurogenic Bladder and Overactive Detrusor that has completed, run by AbbVie. The registered enrollment target is 52 participants, below the 90-participant average among 16 other Neurogenic Bladder trials with a reported enrollment target (42% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192568, a Phase 4 study of Neurogenic Bladder and Overactive Detrusor, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 52 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary.
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 |
What the finished NCT01192568 record still lists
NCT01192568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 90-participant average among 16 other Neurogenic Bladder trials with a reported enrollment target (42% lower).
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.
NCT01192568 lists 10 locations in 9 states (California, Colorado, Georgia).
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.
What interventions are being tested in trial NCT01192568?
The interventions under investigation include: Placebo (DRUG), Oxybutynin (DRUG).
Who is sponsoring clinical trial NCT01192568?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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
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Where NCT01192568's enrollment target sits among peer trials
52 8th of 16 higher than 9 of 16 other Neurogenic Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurogenic Bladder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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