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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 is a Phase 3 study that has completed, run by Otonomy. The registered enrollment target is 501 participants.
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.
Interventions
- DRUG OTO-201 (ciprofloxacin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02600559
The ClinicalTrials.gov registry entry for NCT02600559 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 501 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 (ciprofloxacin) is the first listed.
NCT02600559 reports 0 study locations.
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.
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