Trial · NCT02706730
A 6-Month Extension Study of OTO-104 in Meniere's Disease
NCT02706730, Phase 3, Terminated, Otonomy, Inc.; results first posted 2022-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 6-Month Extension Study of OTO-104 in Meniere's Disease. Trials, record NCT02706730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02706730
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 6-Month Extension Study of OTO-104 in Meniere's Disease
- NCT number
- NCT02706730
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 189 participants, actual
- Lead sponsor
- Otonomy, Inc.
- Conditions
- Meniere's Disease
- Interventions
- OTO-104
- First posted
- 2016-03-11
- Last updated
- 2022-12-14
- Results first posted
- 2022-12-14
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | 6 Months | Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection persisted at the end of study visit (Week 24 \[Month 6\]). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | 6 Months | The 6-month Safety Analysis Set included all subjects who received at least 1 dose of study drug and completed the study at the Month 6 visit. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | OTO-104 | Perforation present: pinhole size | 4 | Participants | |
| Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | OTO-104 | Perforation present: ≤25% tympanic membrane | 3 | Participants | |
| Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | OTO-104 | Perforation present: ≤25% tympanic membrane Perforation present: >25% and ≤50% tympanic membrane | 1 | Participants | |
| Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | OTO-104 | Perforation present: %50 tympanic membrane | 0 | Participants | |
| Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | OTO-104 | Not Present | 113 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OTO-104 | 189 | |
| Overall Study | COMPLETED | OTO-104 | 156 | |
| Overall Study | NOT COMPLETED | OTO-104 | 33 |
Source ClinicalTrials.gov
Adverse events13
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 | Vertigo | Ear and labyrinth disorders | OTO-104 | 7 | 189 | 7 |
| other | Tinnitus | Ear and labyrinth disorders | OTO-104 | 6 | 189 | 6 |
| other | Ear Pain | Ear and labyrinth disorders | OTO-104 | 4 | 189 | 4 |
| other | Tympanic Membrane Perforation | Ear and labyrinth disorders | OTO-104 | 4 | 189 | 4 |
| other | Dizziness | Nervous system disorders | OTO-104 | 5 | 189 | 5 |
| other | Suicidal Ideation | Psychiatric disorders | OTO-104 | 4 | 189 | 4 |
| serious | Hemiplegic Migraine | Nervous system disorders | OTO-104 | 1 | 189 | 1 |
| serious | Omental Infarction and Small Intestinal Obstruction | Gastrointestinal disorders | OTO-104 | 1 | 189 | 1 |
| serious | Acute Myeloid Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | OTO-104 | 1 | 189 | 1 |
| serious | Angina Pectoris | Cardiac disorders | OTO-104 | 1 | 189 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTO-104 | 1 | 189 |
| Total, other adverse events | OTO-104 | 30 | 189 |
| Total, serious adverse events | OTO-104 | 7 | 189 |
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/NCT02706730
GET https://conductscience.org/api/trials/v1/NCT02706730/registered