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Negative Efficacy Results from the recently completed Phase 3 study 104-201506
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This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to be eligible for this open-label extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTO-104 | Experimental | 12 mg dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-104 | Drug | Single intratympanic injection of 12 mg OTO-104 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | 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]). | 6 Months |
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Inclusion Criteria includes, but is not limited to:
Exclusion Criteria includes, but is not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Kathie Bishop, PhD | Otonomy, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many sites in US. Refer to the contact info listed below. | San Diego | California | 92121 | United States |
This study was terminated early based on results of study 104-201506, a US Phase 3 study that indicated no statistically significant difference in the primary endpoint of reduction in definitive vertigo days (DVD) for OTO-104 vs placebo nor for any of the secondary endpoints. Decision was made to terminate all ongoing studies on August 31, 2017, including this study. At the time of termination, 156 subjects completed the study through Month 3 and 121 subjects completed the study through Month 6.
A total of 189 subjects registered for this study and signed informed consent and were enrolled. Of the 189 subjects enrolled, 49 had previously completed the 104-201102 study and 140 had previously completed the 104 201506 study. The first subject enrolled on February 16, 2016, and the last subject completed on September 9, 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | OTO-104 | Intratympanic injection of 12 mg OTO-104 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | OTO-104 | Intratympanic injection of 12 mg OTO-104 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | 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]). | 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. | Posted | Count of Participants | Participants | 6 Months |
|
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Reported or observed during or after dosing with the study drug up until end of study (Month 6).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OTO-104 | Intratympanic injection of 12 mg OTO-104 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemiplegic Migraine | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Otonomy Medical Information Center | Otonomy, Inc. | 1-844-686-4636 | medinfo@otonomy.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2016 | Oct 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Study Terminated by Sponsor |
|
| Subject chose not to receive injection |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Duration of Meniere's disease | Count of Participants | Participants |
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| Participants |
|
|
| 189 |
| 7 |
| 189 |
| 30 |
| 189 |
| Omental Infarction and Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Acute Myeloid Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Deafness, Unilateral | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Tympanic Membrane Perforation | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
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