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NCT02600559 · ClinicalTrials.gov registry record · Phase 3
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
A Phase 3 study, sponsored by Otonomy.
- Completed
- Registry status
- Phase 3
- Development phase
- 501
- Enrollment target
NCT02600559: Completed Phase 3 study, sponsored by Otonomy.
NCT02600559 is a Phase 3 study that has completed, run by Otonomy. The registered enrollment target is 501 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02600559, a Phase 3 study, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 501 participants
- Enrollment target
Study Summary
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
Primary Outcome
Absence or presence of otorrhea (drainage from the middle ear)
Interventions
- DRUG OTO-201 (ciprofloxacin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT02600559 record still lists
NCT02600559 is an interventional study that assigns participants to a tested intervention. The registered 501 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which OTO-201 (ciprofloxacin) is the first listed.
NCT02600559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02600559 about?
NCT02600559 is a clinical study titled "Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes". This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent sur...
What is the current status of trial NCT02600559?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 501 participants. The study started on 2015-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02600559?
The interventions under investigation include: OTO-201 (ciprofloxacin) (DRUG).
Who is sponsoring clinical trial NCT02600559?
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 NCT02600559's enrollment target sits among peer trials
501 743rd of 2000 higher than 1,257 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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