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NCT01949155 · ClinicalTrials.gov registry record · Phase 3
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
A Phase 3 study, sponsored by Otonomy.
- Completed
- Registry status
- Phase 3
- Development phase
- 266
- Enrollment target
NCT01949155 is a Phase 3 study that has completed, run by Otonomy. The registered enrollment target is 266 participants.
The verdict
NCT01949155, a Phase 3 study, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 266 participants
- Enrollment target
Study Summary
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Interventions
- DRUG Sham
- DRUG OTO-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01949155
The ClinicalTrials.gov registry entry for NCT01949155 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otonomy, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT01949155 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01949155 about?
NCT01949155 is a clinical study titled "OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement". The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
What is the current status of trial NCT01949155?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 266 participants. The study started on 2013-11. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01949155?
The interventions under investigation include: Sham (DRUG), OTO-201 (DRUG).
Who is sponsoring clinical trial NCT01949155?
This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.
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