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NCT02768662 · ClinicalTrials.gov registry record · Phase 3
A 6-Month Extension Study of OTO-104 in Meniere's Disease
A Phase 3 study, sponsored by Otonomy.
- Terminated
- Registry status
- Phase 3
- Development phase
- 142
- Enrollment target
NCT02768662: Clinical Trial Phase 3 study, sponsored by Otonomy.
NCT02768662 is a Phase 3 study that was terminated before completion, run by Otonomy. The registered enrollment target is 142 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02768662, a Phase 3 study, was terminated before completion, sponsored by Otonomy.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 142 participants
- Enrollment target
Study Summary
This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.
Primary Outcome
Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks \[Month 6\]).
Interventions
- DRUG OTO-104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2016-08 |
| Est. Completion | 2017-09 |
| Phase | Phase 3 |
Why NCT02768662 stopped before completion
NCT02768662 is an interventional study that assigns participants to a tested intervention. The registered 142 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 (82% lower).
The record links to 0 conditions, and to 1 intervention - of which OTO-104 is the first listed.
NCT02768662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02768662 about?
NCT02768662 is a clinical study titled "A 6-Month Extension Study of OTO-104 in Meniere's Disease". This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligi...
What is the current status of trial NCT02768662?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 142 participants. The study started on 2016-08. Estimated completion is 2017-09.
What interventions are being tested in trial NCT02768662?
The interventions under investigation include: OTO-104 (DRUG).
Who is sponsoring clinical trial NCT02768662?
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 NCT02768662's enrollment target sits among peer trials
142 1559th of 2000 higher than 438 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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