Trial · NCT03664674
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
NCT03664674, Phase 3, Completed, Otonomy, Inc.; results first posted 2022-12-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease. Trials, record NCT03664674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03664674
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
- NCT number
- NCT03664674
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 148 participants, actual
- Lead sponsor
- Otonomy, Inc.
- Conditions
- Meniere Disease
- Interventions
- OTO-104, Placebo
- First posted
- 2018-09-10
- Last updated
- 2022-12-07
- Results first posted
- 2022-12-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 28-Day Average DVD at Week 12 (Month 3) | 3 months | The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject's number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28. |
| Secondary | Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden | 3 Months | The count of days sick at home or bedridden for subsequent intervals was determined during the 4-week period between each visit. The count of days sick at home or bedridden was computed as the sum of the days in the Sick at home and Bedridden categories for each 4-week interval and was standardized to 28 days by multiplying by 28 days and dividing by the number of non-missing diary entries. |
| Secondary | Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit | 3 months | Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum did not heal properly after the injection. Reported here are the Week 12 (Month 3) final visit. |
| Secondary | Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | Week 12 (Month 3) | The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (\<= 10 dB) to impairment at Month 3 (\>10 dB) when measured at 1000 Hz. |
| Secondary | Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | Week 12 (Month 3) | The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (\<= 10 dB) to impairment at Month 3 (\>10 dB) when measured at 2000 Hz. |
| Secondary | Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3) | Week 12 (Month 3) | The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (\<= 10 dB) to impairment at Month 3 (\>10 dB) when measured at 4000 Hz. |
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 | 28-Day Average DVD at Week 12 (Month 3) | 3 months | DVD | LEAST_SQUARES_MEAN | |
| SECONDARY | Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden | 3 Months | days | MEAN | |
| SECONDARY | Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | Week 12 (Month 3) | Subjects that had no impairment at the Baseline visit (air-bone gap \<= 10 dB) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | Week 12 (Month 3) | Subjects that had no impairment at the Baseline visit (air-bone gap \<= 10 dB) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3) | Week 12 (Month 3) | Subjects that had no impairment at the Baseline visit (air-bone gap \<= 10 dB) | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| 28-Day Average DVD at Week 12 (Month 3) | OTO-104 Intent to Treat | 2.869 | 95% Confidence Interval 2.109 to 3.903 | DVD | |
| 28-Day Average DVD at Week 12 (Month 3) | Placebo Intent to Treat | 3.577 | 95% Confidence Interval 2.641 to 4.844 | DVD | |
| Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden | OTO-104 Intent to Treat | 0.998 | Standard Deviation 2.1521 | days | |
| Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden | Placebo Intent to Treat | 1.643 | Standard Deviation 2.5783 | days | |
| Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit | OTO-104 | 0 | Participants | ||
| Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit | Placebo | 0 | Participants | ||
| Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | OTO-104 | 5 | Participants | ||
| Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | Placebo | 7 | Participants | ||
| Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | OTO-104 | 4 | Participants | ||
| Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | Placebo | 4 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OTO-104 | 73 | |
| Overall Study | STARTED | Placebo | 75 | |
| Overall Study | COMPLETED | OTO-104 | 70 | |
| Overall Study | COMPLETED | Placebo | 73 | |
| Overall Study | NOT COMPLETED | OTO-104 | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events30
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 | Meniere's disease | Ear and labyrinth disorders | OTO-104 | 6 | 73 | 6 |
| other | Meniere's disease | Ear and labyrinth disorders | Placebo | 6 | 75 | 6 |
| other | Tinnitus | Ear and labyrinth disorders | OTO-104 | 5 | 73 | 5 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 0 | 75 | 0 |
| other | Vertigo | Ear and labyrinth disorders | OTO-104 | 4 | 73 | 4 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 7 | 75 | 7 |
| other | Ear Discomfort | Ear and labyrinth disorders | OTO-104 | 2 | 73 | 2 |
| other | Ear Discomfort | Ear and labyrinth disorders | Placebo | 2 | 75 | 2 |
| other | Ear Pain | Ear and labyrinth disorders | OTO-104 | 1 | 73 | 1 |
| other | Ear Pain | Ear and labyrinth disorders | Placebo | 4 | 75 | 4 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTO-104 | 0 | 73 |
| Total, all-cause mortality | Placebo | 0 | 75 |
| Total, other adverse events | OTO-104 | 26 | 73 |
| Total, other adverse events | Placebo | 27 | 75 |
| Total, serious adverse events | OTO-104 | 2 | 73 |
| Total, serious adverse events | Placebo | 2 | 75 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37185596 | DERIVED |
Source PubMed
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| OTO-104 vs Placebo: Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit | Trial comparisons |
| OTO-104 vs Placebo: Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3) | Trial comparisons |
| OTO-104 vs Placebo: Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | Trial comparisons |
| OTO-104 vs Placebo: deaths from any cause | Trial comparisons |
| OTO-104 vs Placebo: Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | Trial comparisons |
| OTO-104 vs Placebo: 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/NCT03664674
GET https://conductscience.org/api/trials/v1/NCT03664674/events?page=2