Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
NCT ID: NCT03664674
Last Updated: 2022-12-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2018-08-27
2020-12-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
NCT02717442
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
NCT02612337
Open Label Study of OTO-104 in Subjects With Meniere's Disease
NCT02740387
OTO-104 for the Treatment of Meniere's Disease
NCT01412177
OTO-104 for Meniere's Disease
NCT01084525
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OTO-104
OTO-104
Single intratympanic injection of 12 mg dexamethasone
placebo
Placebo
Single intratympanic injection of placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OTO-104
Single intratympanic injection of 12 mg dexamethasone
Placebo
Single intratympanic injection of placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject has experienced active vertigo during the lead-in period.
* Subject has documented asymmetric sensorineural hearing loss.
* Subject agrees to maintain their current treatments for Meniere's disease while on-study.
Exclusion Criteria
* Subject has a history of immunodeficiency disease.
* Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
* Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
* Subject has a history of vestibular migraine.
* Subject has used an investigational drug or device in the 3 months prior to screening.
* Subject has previously been randomized to a clinical study of OTO-104.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otonomy, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central California Clinical Research
Fresno, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Ear, Nose and Throat Associates of South Florida
Boynton Beach, Florida, United States
Ear Research Foundation
Sarasota, Florida, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Michigan Ear Institute
Farmington Hills, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
Dent Neurologic Institute
Amherst, New York, United States
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Matthews, North Carolina, United States
Piedmont Ear, Nose, and Throat Associates, PA
Winston-Salem, North Carolina, United States
Medical University of South Carolina, Department of Otolaryngology
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Intermountain Ear, Nose & Throat Specialists
Draper, Utah, United States
West Virginia University School of Medicine
Morgantown, West Virginia, United States
Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department
Edegem, , Belgium
UZ Gent - Ear-Nose-Throat Department
Ghent, , Belgium
UZ Leuven - Ear-Nose-Throat Department
Leuven, , Belgium
CHU de Liège - Ear-Nose-Throat Department
Liège, , Belgium
Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie
Aachen, , Germany
Praxis Bad Essen
Bad Essen, , Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
HNO Zentrum am Kudamm
Berlin, , Germany
HNO-Praxis Göttingen
Göttingen, , Germany
HNO Praxis am Neckar
Heidelberg, , Germany
HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
Heidelberg, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
HNO Praxis Dr. med. Roger Fisher
Markkleeberg, , Germany
Klinikum der Universität München
München, , Germany
Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie
Ulm, , Germany
U.O. di Otorinolaringoiatria Universitaria
Bari, NAP, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia
Milan, , Italy
Unità Operativa di Otorinolaringoiatria
Piacenza, , Italy
Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria
Roma, , Italy
10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział
Bydgoszcz, , Poland
Centrum Medyczne ZDROWA
Krakow, , Poland
Centrum Medyczne PROMED
Krakow, , Poland
MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński
Krosno, , Poland
ETG Łódź
Lodz, , Poland
Centrum Słuchu i Mowy Sp. z o.o.
Nadarzyn, , Poland
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina
Rzeszów, , Poland
Agencia Pública Empresarial Sanitaria Hospital de Poniente
El Ejido, Almería, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
Ankara, , Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali
Ankara, , Turkey (Türkiye)
Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu
Ankara, , Turkey (Türkiye)
Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali
Bursa, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
Istanbul, , Turkey (Türkiye)
Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
Izmir, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali
Izmir, , Turkey (Türkiye)
Ninewells Hospital and Medical School
Dundee, Angus, United Kingdom
Royal Victoria Hospital
Belfast, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary
Leicester, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Manchester Head and Neck Centre, Peter Mount Building
Manchester, , United Kingdom
Norfolk & Norwich University Hospital
Norwich, , United Kingdom
The Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
104-201811
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.