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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: Completed Phase 3 study, sponsored by Otonomy.
NCT02350998 is a Phase 3 study that has completed, run by Otonomy. The registered enrollment target is 33 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Interventions
- DRUG OTO-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT02350998 record still lists
NCT02350998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which OTO-201 is the first listed.
NCT02350998 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02350998's enrollment target sits among peer trials
33 1907th of 2000 higher than 92 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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