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NCT01934010 · ClinicalTrials.gov registry record · Phase 3
AM-101 in the Treatment of Post-Acute Tinnitus 1
A Phase 3 study, sponsored by Auris Medical.
- Completed
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
NCT01934010: Completed Phase 3 study, sponsored by Auris Medical.
NCT01934010 is a Phase 3 study that has completed, run by Auris Medical. The registered enrollment target is 260 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01934010, a Phase 3 study, has completed, sponsored by Auris Medical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the safety and local tolerance of repeated treatment cycles of AM-101.
Primary Outcome
Valid for Safety Analysis Set was used. Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound. The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Interventions
- DRUG AM-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2014-06 |
| Est. Completion | 2017-01 |
| Phase | Phase 3 |
What the finished NCT01934010 record still lists
NCT01934010 is an interventional study that assigns participants to a tested intervention. The registered 260 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 (66% lower).
The record links to 0 conditions, and to 1 intervention - of which AM-101 is the first listed.
NCT01934010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01934010 about?
NCT01934010 is a clinical study titled "AM-101 in the Treatment of Post-Acute Tinnitus 1". The purpose of this research study is to test the safety and local tolerance of repeated treatment cycles of AM-101.
What is the current status of trial NCT01934010?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2014-06. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01934010?
The interventions under investigation include: AM-101 (DRUG).
Who is sponsoring clinical trial NCT01934010?
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 NCT01934010's enrollment target sits among peer trials
260 1230th of 2000 higher than 767 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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