Trial · NCT04829214
OTO-313 in Subjects With Unilateral Subjective Tinnitus
NCT04829214, Phase 2, Completed, Otonomy, Inc.; results first posted 2023-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. OTO-313 in Subjects With Unilateral Subjective Tinnitus. Trials, record NCT04829214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04829214
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OTO-313 in Subjects With Unilateral Subjective Tinnitus
- NCT number
- NCT04829214
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 153 participants, actual
- Lead sponsor
- Otonomy, Inc.
- Conditions
- Subjective Tinnitus
- Interventions
- OTO-313, Placebo
- First posted
- 2021-04-02
- Last updated
- 2023-01-06
- Results first posted
- 2023-01-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 | Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder") | The TFI is a validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate a greater problem with tinnitus. A responder is considered as any subject with at least a 13-point improvement from Baseline on the (TFI). This responder analysis required both Week 4 and Week 8 to have a 13-point improvement from Baseline. |
| Secondary | Change From Baseline in Daily Tinnitus Loudness at Week 8 | The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8. | Numerical rating scale (NRS) from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week. |
| Secondary | Change From Baseline in Daily Tinnitus Annoyance at Week 8 | The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8 | Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week. |
| Secondary | Patient Global Impression of Change at Week 8 | Week 8 reported here | Change in overall tinnitus status as perceived by the subject as assessed at the Week 8 visit. Subjects were asked, "Since the beginning of the clinical study, how would you rate your tinnitus?" and had the choice to answer from very much worse (-3) to very much improved (3). The mean change from baseline at Week 8 is reported here. |
| Other | Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit) | After dosing (Baseline) up to end of study (16 Weeks) | Ear examinations were done at every visit. One of the important safety endpoints is an observation of a perforation in the ear drum that did not heal properly after the injection. Reported here are the Week 16 (final visit) results. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 | Week 4 and Week 8 (both had to meet criterion for the subject to be considered a responder) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Baseline in Daily Tinnitus Loudness at Week 8 | The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8. | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in Daily Tinnitus Annoyance at Week 8 | The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8 | units on a scale | MEAN | |
| SECONDARY | Patient Global Impression of Change at Week 8 | Week 8 reported here | score on a scale | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit) | After dosing (Baseline) up to end of study (16 Weeks) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 | OTO-313 Full Analysis Set | 20 | Participants | ||
| Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 | Placebo Full Analysis Set | 27 | Participants | ||
| Change From Baseline in Daily Tinnitus Loudness at Week 8 | OTO-313 Full Analysis Set | -0.67 | Standard Deviation 1.767 | units on a scale | |
| Change From Baseline in Daily Tinnitus Loudness at Week 8 | Placebo Full Analysis Set | -0.90 | Standard Deviation 1.557 | units on a scale | |
| Change From Baseline in Daily Tinnitus Annoyance at Week 8 | OTO-313 Full Analysis Set | -0.73 | Standard Deviation 1.910 | units on a scale | |
| Change From Baseline in Daily Tinnitus Annoyance at Week 8 | Placebo Full Analysis Set | -1.11 | Standard Deviation 1.804 | units on a scale | |
| Patient Global Impression of Change at Week 8 | OTO-313 Full Analysis Set | 0.32 | Standard Error 0.139 | score on a scale | |
| Patient Global Impression of Change at Week 8 | Placebo Full Analysis Set | 0.36 | Standard Error 0.138 | score on a scale | |
| Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit) | OTO-313 Safety Analysis Set | 0 | Participants | ||
| Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit) | Placebo Safety Analysis Set | 0 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | OTO-313 | 77 | |
| Randomization | STARTED | Placebo | 76 | |
| Randomization | COMPLETED | OTO-313 | 77 | |
| Randomization | COMPLETED | Placebo | 76 | |
| Randomization | NOT COMPLETED | OTO-313 | 0 | |
| Randomization | NOT COMPLETED | Placebo | 0 | |
| Follow-up and Efficacy Analysis | STARTED | OTO-313 | 77 | |
| Follow-up and Efficacy Analysis | STARTED | Placebo | 76 | |
| Follow-up and Efficacy Analysis | COMPLETED | OTO-313 | 70 | |
| Follow-up and Efficacy Analysis | COMPLETED | Placebo | 72 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
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 | Hypertension | Vascular disorders | OTO-313 Safety Analysis Set | 0 | 77 | 0 |
| other | Hypertension | Vascular disorders | Placebo Safety Analysis Set | 2 | 76 | 2 |
| other | Blood Potassium Increased | Investigations | OTO-313 Safety Analysis Set | 0 | 77 | 0 |
| other | Blood Potassium Increased | Investigations | Placebo Safety Analysis Set | 2 | 76 | 2 |
| other | Headache | Nervous system disorders | OTO-313 Safety Analysis Set | 1 | 77 | 1 |
| other | Headache | Nervous system disorders | Placebo Safety Analysis Set | 2 | 76 | 2 |
| other | Tinnitus | Ear and labyrinth disorders | OTO-313 Safety Analysis Set | 8 | 77 | 8 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo Safety Analysis Set | 8 | 76 | 8 |
| other | Vertigo | Ear and labyrinth disorders | OTO-313 Safety Analysis Set | 2 | 77 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Placebo Safety Analysis Set | 1 | 76 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTO-313 Safety Analysis Set | 0 | 77 |
| Total, all-cause mortality | Placebo Safety Analysis Set | 0 | 76 |
| Total, other adverse events | OTO-313 Safety Analysis Set | 23 | 77 |
| Total, other adverse events | Placebo Safety Analysis Set | 24 | 76 |
| Total, serious adverse events | OTO-313 Safety Analysis Set | 2 | 77 |
| Total, serious adverse events | Placebo Safety Analysis Set | 0 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| OTO-313 Safety Analysis Set vs Placebo Safety Analysis Set: Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit) | Trial comparisons |
| OTO-313 Full Analysis Set vs Placebo Full Analysis Set: Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 | Trial comparisons |
| OTO-313 Safety Analysis Set vs Placebo Safety Analysis Set: deaths from any cause | Trial comparisons |
| OTO-313 Safety Analysis Set vs Placebo Safety Analysis Set: serious adverse events | Trial comparisons |
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/NCT04829214
GET https://conductscience.org/api/trials/v1/NCT04829214/events?page=2