Trial · NCT01934010
AM-101 in the Treatment of Post-Acute Tinnitus 1
NCT01934010, Phase 3, Completed, Auris Medical, Inc.; results first posted 2018-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. AM-101 in the Treatment of Post-Acute Tinnitus 1. Trials, record NCT01934010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01934010
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AM-101 in the Treatment of Post-Acute Tinnitus 1
- NCT number
- NCT01934010
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 260 participants, actual
- Lead sponsor
- Auris Medical, Inc.
- Conditions
- Tinnitus
- Interventions
- AM-101
- First posted
- 2013-09-04
- Last updated
- 2018-05-16
- Results first posted
- 2018-03-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction) | Day 1 (TV1) to Day 35 (FUV2) of cycle 1 | 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. |
| Primary | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction) | Day 84 (TV4) to Day 119 (FUV5) of cycle 2 | 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. |
| Primary | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction) | Day 168 (TV7) up to Day 203 (FUV8) of cycle 3 | 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. |
| Secondary | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction) | Day 1 (TV1) to Day 84 (FUV3) of cycle 1 | 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. |
| Secondary | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction) | Day 84 (TV4) to Day 168 (FUV6) of cycle 2 | 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. |
| Secondary | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction) | Day 168 (TV7) to Day 252 (FUV9) of cycle 3 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction) | Day 1 (TV1) to Day 35 (FUV2) of cycle 1 | The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available. | Number subject affected | NUMBER |
| PRIMARY | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction) | Day 84 (TV4) to Day 119 (FUV5) of cycle 2 | The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.~Subjects from Cycle 1 did not participate in Cycle 2 and 3 and are therefore zero. | Number subject affected | NUMBER |
| PRIMARY | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction) | Day 168 (TV7) up to Day 203 (FUV8) of cycle 3 | Number subject affected | NUMBER | |
| SECONDARY | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction) | Day 1 (TV1) to Day 84 (FUV3) of cycle 1 | The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available. | Number subject affected | NUMBER |
| SECONDARY | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction) | Day 84 (TV4) to Day 168 (FUV6) of cycle 2 | The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available. | Number subject affected | NUMBER |
| SECONDARY | Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction) | Day 168 (TV7) to Day 252 (FUV9) of cycle 3 | The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available. | Number subject affected | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction) | 1 Cycle AM-101 | 10 | Number subject affected | ||
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction) | 2 Cycles AM-101 | 2 | Number subject affected | ||
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction) | 3 Cycles AM-101 | 2 | Number subject affected | ||
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction) | 2 Cycles AM-101 | 1 | Number subject affected | ||
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction) | 3 Cycles AM-101 | 0 | Number subject affected | ||
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction) | 3 Cycles AM-101 | 2 | Number subject affected | ||
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction) | 1 Cycle AM-101 | 10 | Number subject affected | ||
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction) | 2 Cycles AM-101 | 3 | Number subject affected | ||
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction) | 3 Cycles AM-101 | 0 | Number subject affected | ||
| Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction) | 2 Cycles AM-101 | 0 | Number subject affected |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1 Cycle AM-101 | 114 | |
| Overall Study | STARTED | 2 Cycles AM-101 | 67 | |
| Overall Study | STARTED | 3 Cycles AM-101 | 76 | |
| Overall Study | COMPLETED | 1 Cycle AM-101 | 91 | |
| Overall Study | COMPLETED | 2 Cycles AM-101 | 56 | |
| Overall Study | COMPLETED | 3 Cycles AM-101 | 74 | |
| Overall Study | NOT COMPLETED | 1 Cycle AM-101 | 23 | |
| Overall Study | NOT COMPLETED | 2 Cycles AM-101 | 11 | |
| Overall Study | NOT COMPLETED | 3 Cycles AM-101 | 2 |
Source ClinicalTrials.gov
Adverse events69
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | 1 Cycle AM-101 | 5 | 114 | |
| other | Headache | Nervous system disorders | 2 Cycles AM-101 | 7 | 67 | |
| other | Headache | Nervous system disorders | 3 Cycles AM-101 | 9 | 76 | |
| other | Ear discomfort | Ear and labyrinth disorders | 1 Cycle AM-101 | 3 | 114 | |
| other | Ear discomfort | Ear and labyrinth disorders | 2 Cycles AM-101 | 9 | 67 | |
| other | Ear discomfort | Ear and labyrinth disorders | 3 Cycles AM-101 | 7 | 76 | |
| other | Ear pain | Ear and labyrinth disorders | 1 Cycle AM-101 | 10 | 114 | |
| other | Ear pain | Ear and labyrinth disorders | 2 Cycles AM-101 | 13 | 67 | |
| other | Ear pain | Ear and labyrinth disorders | 3 Cycles AM-101 | 8 | 76 | |
| other | Hypoacusis | Ear and labyrinth disorders | 1 Cycle AM-101 | 5 | 114 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 Cycle AM-101 | ||
| Total, all-cause mortality | 2 Cycles AM-101 | ||
| Total, all-cause mortality | 3 Cycles AM-101 | ||
| Total, other adverse events | 1 Cycle AM-101 | 25 | 114 |
| Total, other adverse events | 2 Cycles AM-101 | 25 | 67 |
| Total, other adverse events | 3 Cycles AM-101 | 37 | 76 |
| Total, serious adverse events | 1 Cycle AM-101 | 2 | 114 |
| Total, serious adverse events | 2 Cycles AM-101 | 1 | 67 |
| Total, serious adverse events | 3 Cycles AM-101 | 1 | 76 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01934010
GET https://conductscience.org/api/trials/v1/NCT01934010/events?page=2