Trial · NCT02717442
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
NCT02717442, Phase 3, Terminated, Otonomy, Inc.; results first posted 2023-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of OTO-104 in Subjects With Unilateral Meniere's Disease. Trials, record NCT02717442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02717442
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of OTO-104 in Subjects With Unilateral Meniere's Disease
- NCT number
- NCT02717442
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 176 participants, actual
- Lead sponsor
- Otonomy, Inc.
- Conditions
- Meniere's Disease
- Interventions
- OTO-104, Placebo
- First posted
- 2016-03-23
- Last updated
- 2023-01-13
- Results first posted
- 2023-01-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-1 Population | 3 months | In the Full Analysis Set (FAS)-1 population, the number of DVDs at Week 12 (the 4-week \[28 days\] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. |
| Primary | The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population | 3 months | The number of DVDs at Week 12 (the 4-week \[28 days\] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. |
| Secondary | Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-1 | 3 months | Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system: 0 = normal activity 1. = slight limitation 2. = moderate limitation 3. = sick at home 4. = bedridden |
| Secondary | Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-2 | 3 months | Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system: 0 = normal activity 1. = slight limitation 2. = moderate limitation 3. = sick at home 4. = bedridden |
| Secondary | Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) | 3 months | Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection at the Baseline visit persisted at the end of study visit (Week12 \[Month 3\]). Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. |
| Secondary | Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3) | 3 Months | The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment (\<=10 dB) to impairment (\>10 dB) when measure at 500 Hz. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. |
| Secondary | Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | 3 months | 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. Week 12 (Month 3) = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. |
| Secondary | Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | 3 months | 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. Week 12 (Month 3) = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-1 Population | 3 months | A subject is included in the analysis if they received study drug, had a baseline definitive vertigo measurement for the 4-week lead-in period and at least one 4-week definitive vertigo measurement post-baseline, i.e., at least one post-baseline daily diary entry. The model and corresponding method of estimation adjusted for overdispersion and addressed missing 4-week intervals under the assumption of Missing at Random (MAR). | Definitive Vertigo Day | MEAN |
| PRIMARY | The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population | 3 months | The FAS - 2 includes all subjects from FAS-1 who were randomized 12 weeks prior to the study termination decision date of August 31, 2017 (i.e., subjects that had the opportunity to complete 12 weeks of daily diary entries in the study at the time of study termination). | Definitive Vertigo Day | MEAN |
| SECONDARY | Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-1 | 3 months | A subject is included in the analysis if they received study drug, had a baseline definitive vertigo measurement for the 4-week lead-in period and at least one 4-week definitive vertigo measurement post-baseline, i.e., at least one post-baseline daily diary entry. The model and corresponding method of estimation adjusted for overdispersion and addressed missing 4-week intervals under the assumption of Missing at Random (MAR). | days | MEAN |
| SECONDARY | Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-2 | 3 months | days | MEAN | |
| SECONDARY | Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) | 3 months | Only subjects that had a Month 3 otoscopic examination are included in assessment of this emdpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3) | 3 Months | Subjects that had no impairment at the baseline visit (air-bone gap \<=10 dB) and had an audiogram collected at the Week 12 (Month 3) visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | 3 months | Subjects that had no impairment at the baseline visit (air-bone gap \<=10 dB) and had an audiogram collected at the Week 12 (Month 3) visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | 3 months | Subjects that had no impairment at the baseline visit (air-bone gap \<=10 dB) and had an audiogram collected at the Week 12 (Month 3) visit. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-1 Population | OTO-104 (Full Analysis Set -1) | 2.336 | 95% Confidence Interval 1.747 to 3.125 | Definitive Vertigo Day | |
| The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-1 Population | Placebo (Full Analysis Set - 1) | 3.549 | 95% Confidence Interval 2.763 to 4.560 | Definitive Vertigo Day | |
| The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population | OTO-104 (Full Analysis Set -2) | 2.044 | 95% Confidence Interval 1.480 to 2.822 | Definitive Vertigo Day | |
| The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population | Placebo (Full Analysis Set - 2) | 3.467 | 95% Confidence Interval 2.617 to 4.594 | Definitive Vertigo Day | |
| Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-1 | OTO-104 (Full Analysis Set -1) | 1.2 | Standard Deviation 2.32 | days | |
| Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-1 | Placebo (Full Analysis Set - 1) | 2.3 | Standard Deviation 4.58 | days | |
| Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-2 | OTO-104 (Full Analysis Set- 2) | 1.2 | Standard Deviation 2.18 | days | |
| Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-2 | Placebo (FAS-2) | 2.2 | Standard Deviation 4.68 | days | |
| Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) | OTO-104 (Safety Analysis Set) | 1 | Participants | ||
| Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) | Placebo (Safety Analysis Set) | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 | 88 | |
| Overall Study | STARTED | Placebo | 88 | |
| Overall Study | COMPLETED | OTO-104 | 53 | |
| Overall Study | COMPLETED | Placebo | 59 | |
| Overall Study | NOT COMPLETED | OTO-104 | 35 | |
| Overall Study | NOT COMPLETED | Placebo | 29 |
Source ClinicalTrials.gov
Adverse events34
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 | OTO-104 (Safety Analysis Set) | 9 | 86 | 86 |
| other | Headache | Nervous system disorders | Placebo (Safety Analysis Set) | 7 | 88 | 88 |
| other | Dizziness | Nervous system disorders | OTO-104 (Safety Analysis Set) | 7 | 86 | 7 |
| other | Dizziness | Nervous system disorders | Placebo (Safety Analysis Set) | 4 | 88 | 4 |
| other | Dysgeusia | Nervous system disorders | OTO-104 (Safety Analysis Set) | 3 | 86 | 3 |
| other | Dysgeusia | Nervous system disorders | Placebo (Safety Analysis Set) | 2 | 88 | 2 |
| other | Hypoesthesia | Nervous system disorders | OTO-104 (Safety Analysis Set) | 2 | 86 | 2 |
| other | Hypoesthesia | Nervous system disorders | Placebo (Safety Analysis Set) | 0 | 88 | 0 |
| other | Meniere's Disease | Ear and labyrinth disorders | OTO-104 (Safety Analysis Set) | 5 | 86 | 5 |
| other | Meniere's Disease | Ear and labyrinth disorders | Placebo (Safety Analysis Set) | 1 | 88 | 1 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTO-104 (Safety Analysis Set) | 0 | 86 |
| Total, all-cause mortality | Placebo (Safety Analysis Set) | 0 | 88 |
| Total, other adverse events | OTO-104 (Safety Analysis Set) | 52 | 86 |
| Total, other adverse events | Placebo (Safety Analysis Set) | 29 | 88 |
| Total, serious adverse events | OTO-104 (Safety Analysis Set) | 2 | 86 |
| Total, serious adverse events | Placebo (Safety Analysis Set) | 0 | 88 |
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 (Safety Analysis Set) vs Placebo (Safety Analysis Set): Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) | Trial comparisons |
| OTO-104 (Safety Analysis Set) vs Placebo (Safety Analysis Set): Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | Trial comparisons |
| OTO-104 (Safety Analysis Set) vs Placebo (Safety Analysis Set): Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | Trial comparisons |
| OTO-104 (Safety Analysis Set) vs Placebo (Safety Analysis Set): Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3) | Trial comparisons |
| OTO-104 (Safety Analysis Set) vs Placebo (Safety Analysis Set): deaths from any cause | Trial comparisons |
| OTO-104 (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/NCT02717442
GET https://conductscience.org/api/trials/v1/NCT02717442/events?page=2