Trial · NCT02768662

A 6-Month Extension Study of OTO-104 in Meniere's Disease

NCT02768662, Phase 3, Terminated, Otonomy, Inc.; results first posted 2023-01-20

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 NCT02768662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02768662

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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: NCT02768662
Status: Terminated
Phases: Phase 3
Enrollment: 142 participants, actual
Lead sponsor: Otonomy, Inc.
Conditions: Meniere's Disease
Interventions: OTO-104
First posted: 2016-05-11
Last updated: 2023-01-20
Results first posted: 2023-01-20

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 exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks \[Month 6\]).

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 Month 6 visit	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)	OTO-104	Perforation present: pinhole size	0	Participants
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)	OTO-104	Perforation present: ≤25% tympanic membrane	0	Participants
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)	OTO-104	Perforation present: >25% and ≤50% tympanic membrane	0	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	Perforation not present	56	Participants
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)	OTO-104	Perforation information missing	0	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	OTO-104	142
Overall Study	COMPLETED	OTO-104	56
Overall Study	NOT COMPLETED	OTO-104	86

Source ClinicalTrials.gov

Adverse events15

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	Nasopharyngitis	Infections and infestations	OTO-104	3	142	3
other	Urinary Tract Infection	Infections and infestations	OTO-104	3	142	3
other	Tinnitus	Ear and labyrinth disorders	OTO-104	5	142	5
other	Vertigo	Ear and labyrinth disorders	OTO-104	4	142	4
other	Meniere's Disease	Ear and labyrinth disorders	OTO-104	3	142	3
other	Headache	Nervous system disorders	OTO-104	4	142	4
other	Dizziness	Nervous system disorders	OTO-104	3	142	3
other	Arthralgia	Musculoskeletal and connective tissue disorders	OTO-104	3	142	3
other	Nausea	Gastrointestinal disorders	OTO-104	3	142	3
other	Injection Site Discomfort	General disorders	OTO-104	3	142	3

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OTO-104	0	142
Total, other adverse events	OTO-104	37	142
Total, serious adverse events	OTO-104	4	142

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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GET https://conductscience.org/api/trials/v1/NCT02768662/registered

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