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The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTO-104 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-104 | Drug | Single intratympanic injection of 12 mg dexamethasone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 28-Day Average DVD at Week 12 (Month 3) | The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject's number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden | The count of days sick at home or bedridden for subsequent intervals was determined during the 4-week period between each visit. The count of days sick at home or bedridden was computed as the sum of the days in the Sick at home and Bedridden categories for each 4-week interval and was standardized to 28 days by multiplying by 28 days and dividing by the number of non-missing diary entries. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California Clinical Research | Fresno | California | 93720 | United States | ||
| University of Colorado School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37185596 | Derived | Phillips J, Mikulec AA, Robinson JM, Skarinsky D, Anderson JJ. Efficacy of Intratympanic OTO-104 for the Treatment of Meniere's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies. Otol Neurotol. 2023 Jul 1;44(6):584-592. doi: 10.1097/MAO.0000000000003886. Epub 2023 Apr 22. |
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In addition to meeting all screening visit inclusion criteria, potential subjects had to experience and record at least 4 and a maximum of 22 definitive vertigo day (DVD) during the 4-week lead-in period, where no intervention was administered. Also, the subject needed to complete at least 22 of 28 diary entries during this lead-in period. A DVD was defined as each day the subject recorded a vertigo episode lasting at least 20 minutes corresponding to a vertigo score of 2 or more.
148 subjects were randomized and 148 subjects received study drug. The most common reason for screen failure was that there was not a sufficient number of definitive vertigo days in the 28-day lead-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | OTO-104 | OTO-104: Single intratympanic injection of 12 mg dexamethasone |
| FG001 | Placebo | Placebo: Single intratympanic injection of placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jul 30, 2020 |
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Randomized, Double-blind, Placebo-controlled, Multicenter
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| Placebo |
| Drug |
Single intratympanic injection of placebo |
|
| 3 Months |
| Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit | Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum did not heal properly after the injection. Reported here are the Week 12 (Month 3) final visit. | 3 months |
| Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | 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) |
| Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | 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) |
| Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3) | 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 4000 Hz. | Week 12 (Month 3) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80909 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Ear, Nose and Throat Associates of South Florida | Boynton Beach | Florida | 33426 | United States |
| Ear Research Foundation | Sarasota | Florida | 34239 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Michigan Ear Institute | Farmington Hills | Michigan | 48334 | United States |
| Saint Louis University | St Louis | Missouri | 63110 | United States |
| Dent Neurologic Institute | Amherst | New York | 14226 | United States |
| New York Eye and Ear Infirmary of Mount Sinai | New York | New York | 10003 | United States |
| Charlotte Eye Ear Nose & Throat Associates, P.A. | Matthews | North Carolina | 28105 | United States |
| Piedmont Ear, Nose, and Throat Associates, PA | Winston-Salem | North Carolina | 27103 | United States |
| Medical University of South Carolina, Department of Otolaryngology | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Intermountain Ear, Nose & Throat Specialists | Draper | Utah | 84020 | United States |
| West Virginia University School of Medicine | Morgantown | West Virginia | 26506 | United States |
| Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department | Edegem | 2650 | Belgium |
| UZ Gent - Ear-Nose-Throat Department | Ghent | 9000 | Belgium |
| UZ Leuven - Ear-Nose-Throat Department | Leuven | 3000 | Belgium |
| CHU de Liège - Ear-Nose-Throat Department | Liège | 4000 | Belgium |
| Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie | Aachen | 52074 | Germany |
| Praxis Bad Essen | Bad Essen | 49152 | Germany |
| Charité Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| HNO Zentrum am Kudamm | Berlin | 10629 | Germany |
| HNO-Praxis Göttingen | Göttingen | 37073 | Germany |
| HNO Praxis am Neckar | Heidelberg | 69120 | Germany |
| HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich | Heidelberg | 69126 | Germany |
| Universitätsklinikum Mannheim | Mannheim | 68167 | Germany |
| HNO Praxis Dr. med. Roger Fisher | Markkleeberg | 04416 | Germany |
| Klinikum der Universität München | München | 81377 | Germany |
| Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie | Ulm | 89075 | Germany |
| U.O. di Otorinolaringoiatria Universitaria | Bari | NAP | 70124 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia | Milan | 20122 | Italy |
| Unità Operativa di Otorinolaringoiatria | Piacenza | 29121 | Italy |
| Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria | Roma | 00189 | Italy |
| 10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział | Bydgoszcz | 85-681 | Poland |
| Centrum Medyczne ZDROWA | Krakow | 31-216 | Poland |
| Centrum Medyczne PROMED | Krakow | 31-411 | Poland |
| MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński | Krosno | 38-400 | Poland |
| ETG Łódź | Lodz | 90-302 | Poland |
| Centrum Słuchu i Mowy Sp. z o.o. | Nadarzyn | 05-830 | Poland |
| Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina | Rzeszów | 35-055 | Poland |
| Agencia Pública Empresarial Sanitaria Hospital de Poniente | El Ejido | Almería | 04700 | Spain |
| Hospital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali | Ankara | 06100 | Turkey (Türkiye) |
| Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali | Ankara | 06490 | Turkey (Türkiye) |
| Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu | Ankara | 06530 | Turkey (Türkiye) |
| Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali | Bursa | 16059 | Turkey (Türkiye) |
| Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali | Istanbul | 34093 | Turkey (Türkiye) |
| Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu | Istanbul | 34457 | Turkey (Türkiye) |
| Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali | Izmir | 35100 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali | Izmir | 35340 | Turkey (Türkiye) |
| Ninewells Hospital and Medical School | Dundee | Angus | DD19SY | United Kingdom |
| Royal Victoria Hospital | Belfast | BT126BA | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB20QQ | United Kingdom |
| University Hospital of Wales | Cardiff | CF144XW | United Kingdom |
| Gloucestershire Royal Hospital | Gloucester | GL13NN | United Kingdom |
| University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary | Leicester | LE15WW | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE19RT | United Kingdom |
| Manchester Head and Neck Centre, Peter Mount Building | Manchester | M139WL | United Kingdom |
| Norfolk & Norwich University Hospital | Norwich | NR47UY | United Kingdom |
| The Royal Hallamshire Hospital | Sheffield | S102JF | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
This population is designated as the Safety Analysis Set, which is comprised of all subjects that were randomized and received study drug. They are grouped based on what they received, not what they were randomized to receive.
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| ID | Title | Description |
|---|---|---|
| BG000 | OTO-104 | OTO-104: Single intratympanic injection of 12 mg dexamethasone |
| BG001 | Placebo | Placebo: Single intratympanic injection of placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Duration of Meniere's disease | Count of Participants | Participants |
|
| 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 | 28-Day Average DVD at Week 12 (Month 3) | The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject's number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28. | Posted | Least Squares Mean | 95% Confidence Interval | DVD | 3 months |
|
|
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| Secondary | Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden | The count of days sick at home or bedridden for subsequent intervals was determined during the 4-week period between each visit. The count of days sick at home or bedridden was computed as the sum of the days in the Sick at home and Bedridden categories for each 4-week interval and was standardized to 28 days by multiplying by 28 days and dividing by the number of non-missing diary entries. | Posted | Mean | Standard Deviation | days | 3 Months |
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| Secondary | Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit | Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum did not heal properly after the injection. Reported here are the Week 12 (Month 3) final visit. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | 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. | Subjects that had no impairment at the Baseline visit (air-bone gap <= 10 dB) | Posted | Count of Participants | Participants | Week 12 (Month 3) |
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| Secondary | Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | 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. | Subjects that had no impairment at the Baseline visit (air-bone gap <= 10 dB) | Posted | Count of Participants | Participants | Week 12 (Month 3) |
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| Secondary | Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3) | 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 4000 Hz. | Subjects that had no impairment at the Baseline visit (air-bone gap <= 10 dB) | Posted | Count of Participants | Participants | Week 12 (Month 3) |
|
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Reported or observed during or after dosing with the study drug up until end of study (Week 12/Month 3).
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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 | OTO-104: Single intratympanic injection of 12 mg dexamethasone | 0 | 73 | 2 | 73 | 26 | 73 |
| EG001 | Placebo | Placebo: Single intratympanic injection of placebo | 0 | 75 | 2 | 75 | 27 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Uterine Haemorrhage | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment | Subject was also hospitalized for hypertension the day after being discharged following recovery of exacerbation of Meniere's disease. |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meniere's disease | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ear Discomfort | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Tympanic Membrane Disorders | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Otonomy Medical Information Center | Otonomy, Inc. | 1-844-686-4636 | medinfo@otonomy.com |
| Oct 14, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| D014717 | Vertigo |
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Belgium |
|
| United States |
|
| Poland |
|
| Italy |
|
| United Kingdom |
|
| Germany |
|
| Spain |
|
| 6-10 years |
|
| 11-15 years |
|
| >15 years |
|
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