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NCT01803646 · ClinicalTrials.gov registry record · Phase 3
AM-101 in the Treatment of Acute Tinnitus 2
A Phase 3 study of Tinnitus, sponsored by Auris Medical.
- Completed
- Registry status
- Phase 3
- Development phase
- 343
- Enrollment target
- 1
- Study location
NCT01803646: Completed Phase 3 study of Tinnitus, sponsored by Auris Medical.
NCT01803646 is a Phase 3 study of Tinnitus that has completed, run by Auris Medical. The registered enrollment target is 343 participants, below the 12,605-participant average among 24 other Tinnitus trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01803646, a Phase 3 study of Tinnitus, has completed, sponsored by Auris Medical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 343 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months.
Primary Outcome
Starting at the screening visit (SV), each subject recorded the following numerical rating scales (NRS) throughout the entire study duration: \- Tinnitus loudness "at its loudest" within the last 24 hours (Tinnitus Loudness Questionnaire \[TLQ\] NRSLoudest). Subjects were asked "On a scale from 0 to 10, where 0 represents no tinnitus and 10 represents extremely loud tinnitus, what one number best describes your tinnitus at its loudest in the last 24 hours (including right now)?" TLQ NRSLoudest
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AM-101
Study Locations (1)
Ohio
- Medpace - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT01803646 record still lists
NCT01803646 is an interventional study that assigns participants to a tested intervention. The registered 343 participants enrollment target is mid-sized for trials with a published cap, below the 12,605-participant average among 24 other Tinnitus trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Tinnitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01803646 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01803646 about?
NCT01803646 is a clinical study titled "AM-101 in the Treatment of Acute Tinnitus 2". The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the ...
What is the current status of trial NCT01803646?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 343 participants. The study started on 2014-02. Estimated completion is 2016-06.
What conditions does trial NCT01803646 study?
This clinical trial studies the following conditions: Tinnitus.
What interventions are being tested in trial NCT01803646?
The interventions under investigation include: Placebo (DRUG), AM-101 (DRUG).
Who is sponsoring clinical trial NCT01803646?
This trial is sponsored by Auris Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01803646 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tinnitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01803646's enrollment target sits among peer trials
343 3rd of 24 higher than 22 of 24 other Tinnitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tinnitus 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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