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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 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (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 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]). | 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 Europe. 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, 90 subjects completed the study through Month 3 and 56 subjects completed the study through Month 6.
A total of 142 subjects were enrolled. Of the 142 subjects enrolled, 46 had previously completed the 104-201403 study and 96 had previously completed the 104 201508 study. The first subject enrolled on August 25, 2016, and the last subject completed on September 8, 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 | 12 mg dexamethasone 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 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]). | The 6-month Safety Analysis Set included all subjects who received at least 1 dose of study drug and completed 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 the end of the 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 | 12 mg dexamethasone OTO-104: Intratympanic injection of 12 mg OTO-104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain and Constipation | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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 | Apr 26, 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 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| 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 |
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| 0 |
| 142 |
| 4 |
| 142 |
| 37 |
| 142 |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | 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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| Vertigo | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Meniere's Disease | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Injection Site Discomfort | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Procedural Dizziness | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
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