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NCT02809118 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
A Phase 3 study, sponsored by Auris Medical.
- Terminated
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
NCT02809118: Clinical Trial Phase 3 study, sponsored by Auris Medical.
NCT02809118 is a Phase 3 study that was terminated before completion, run by Auris Medical. The registered enrollment target is 56 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02809118, a Phase 3 study, was terminated before completion, sponsored by Auris Medical.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
Study Summary
The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).
Primary Outcome
Measurement of the recovery of hearing between Day 0 (before treatment) and Day 91, i.e. change in pure tone audiometry between Day 0 and Day 91. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
Interventions
- OTHER Placebo
- DRUG AM-111 0.4 mg/ml
- DRUG AM-111 0.8 mg/ml
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2016-06 |
| Est. Completion | 2018-02 |
| Phase | Phase 3 |
Why NCT02809118 stopped before completion
NCT02809118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02809118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02809118 about?
NCT02809118 is a clinical study titled "Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment". The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).
What is the current status of trial NCT02809118?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2016-06. Estimated completion is 2018-02.
What interventions are being tested in trial NCT02809118?
The interventions under investigation include: Placebo (OTHER), AM-111 0.4 mg/ml (DRUG), AM-111 0.8 mg/ml (DRUG).
Who is sponsoring clinical trial NCT02809118?
This trial is sponsored by Auris Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02809118's enrollment target sits among peer trials
56 1827th of 2000 higher than 167 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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