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NCT02408796 · ClinicalTrials.gov registry record · Phase 2
Open-Label Study of OTO-201 for Treatment of AOMT
A Phase 2 study, sponsored by Otonomy.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT02408796: Completed Phase 2 study, sponsored by Otonomy.
NCT02408796 is a Phase 2 study that has completed, run by Otonomy. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02408796, a Phase 2 study, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.
Primary Outcome
Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection.
Interventions
- DRUG OTO-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT02408796 record still lists
NCT02408796 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which OTO-201 is the first listed.
NCT02408796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02408796 about?
NCT02408796 is a clinical study titled "Open-Label Study of OTO-201 for Treatment of AOMT". This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety...
What is the current status of trial NCT02408796?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2015-03. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02408796?
The interventions under investigation include: OTO-201 (DRUG).
Who is sponsoring clinical trial NCT02408796?
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 NCT02408796's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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