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NCT00909181 · ClinicalTrials.gov registry record · Phase 3
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
A Phase 3 study, sponsored by Antares Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 626
- Enrollment target
NCT00909181: Completed Phase 3 study, sponsored by Antares Pharma.
NCT00909181 is a Phase 3 study that has completed, run by Antares Pharma. The registered enrollment target is 626 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00909181, a Phase 3 study, has completed, sponsored by Antares Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 626 participants
- Enrollment target
Study Summary
The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel. The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.
Primary Outcome
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
Interventions
- DRUG Placebo
- DRUG Oxybutynin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 626 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00909181 record still lists
NCT00909181 is an interventional study that assigns participants to a tested intervention. The registered 626 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00909181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00909181 about?
NCT00909181 is a clinical study titled "Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence". The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel. The hypothesis is ...
What is the current status of trial NCT00909181?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 626 participants. The study started on 2009-03. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00909181?
The interventions under investigation include: Placebo (DRUG), Oxybutynin (DRUG).
Who is sponsoring clinical trial NCT00909181?
This trial is sponsored by Antares Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00909181's enrollment target sits among peer trials
626 586th of 2000 higher than 1,415 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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