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NCT02350998 · ClinicalTrials.gov registry record · Phase 3
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
A Phase 3 study, sponsored by Otonomy.
- Completed
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
NCT02350998 is a Phase 3 study that has completed, run by Otonomy. The registered enrollment target is 33 participants.
The verdict
NCT02350998, a Phase 3 study, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
Study Summary
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.
Interventions
- DRUG OTO-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02350998
The ClinicalTrials.gov registry entry for NCT02350998 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 33 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 1 intervention - of which OTO-201 is the first listed.
NCT02350998 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02350998 about?
NCT02350998 is a clinical study titled "Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration". This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen ...
What is the current status of trial NCT02350998?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2015-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02350998?
The interventions under investigation include: OTO-201 (DRUG).
Who is sponsoring clinical trial NCT02350998?
This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.
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