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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 is a Phase 3 study that has completed, run by Antares Pharma. The registered enrollment target is 626 participants.
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.
Interventions
- DRUG Placebo
- DRUG Oxybutynin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 626 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00909181
The ClinicalTrials.gov registry entry for NCT00909181 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 626 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Antares Pharma, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00909181 reports 0 study locations.
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.
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