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NCT02612337 · ClinicalTrials.gov registry record · Phase 3
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
A Phase 3 study, sponsored by Otonomy.
- Completed
- Registry status
- Phase 3
- Development phase
- 166
- Enrollment target
NCT02612337: Completed Phase 3 study, sponsored by Otonomy.
NCT02612337 is a Phase 3 study that has completed, run by Otonomy. The registered enrollment target is 166 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02612337, a Phase 3 study, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 166 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Primary Outcome
The number of DVDs at Week 12 (defined as the 4-week \[28 days\] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. Baseline occurred at the end of lead-in and no intervention was administered during lead-in.
Interventions
- DRUG Placebo
- DRUG OTO-104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2015-10-27 |
| Est. Completion | 2017-07-18 |
| Phase | Phase 3 |
What the finished NCT02612337 record still lists
NCT02612337 is an interventional study that assigns participants to a tested intervention. The registered 166 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 (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02612337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02612337 about?
NCT02612337 is a clinical study titled "Study of OTO-104 in Subjects With Unilateral Meniere's Disease". The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
What is the current status of trial NCT02612337?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2015-10-27. Estimated completion is 2017-07-18.
What interventions are being tested in trial NCT02612337?
The interventions under investigation include: Placebo (DRUG), OTO-104 (DRUG).
Who is sponsoring clinical trial NCT02612337?
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 NCT02612337's enrollment target sits among peer trials
166 1463rd of 2000 higher than 536 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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