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Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03664674
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Brief Summary:
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

Condition or disease Intervention/treatment Phase
Meniere Disease Drug: OTO-104 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-blind, Placebo-controlled, Multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OTO-104 Drug: OTO-104
Single intratympanic injection of 12 mg dexamethasone

Placebo Comparator: placebo Drug: Placebo
Single intratympanic injection of placebo




Primary Outcome Measures :
  1. The number of definitive vertigo days [ Time Frame: 3 months ]
    subject diary


Secondary Outcome Measures :
  1. Audiometry [ Time Frame: 3 months ]
    assessment of hearing function

  2. Otoscopic examination - use of an otoscope to assess the health of the ear [ Time Frame: 3 months ]
    assessment of the auditory canal and tympanic membrane

  3. Adverse events [ Time Frame: 3 months ]
    medical events reported by the subject

  4. Impact of vertigo experience on daily activities [ Time Frame: 3 Months ]
    subject diary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
  • 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 is pregnant or lactating.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664674


Contacts
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Contact: Clinical Study Manager otonomyclinicaltrials@otonomy.com

Locations
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United States, California
Central California Clinical Research Recruiting
Fresno, California, United States, 93720
Contact: Aimee Martinez    559-432-3303 ext 206    amartinez@ccent.com   
United States, Colorado
University of Colorado School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristi Folchert    303-724-9528    kristi.englefolchert@ucdenver.edu   
Colorado ENT & Allergy Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Debbie Bothwell    719-867-7810    dbothwell@coloradoent.com   
United States, Connecticut
Yale University School of Medicine Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Ear, Nose and Throat Associates of South Florida Recruiting
Boynton Beach, Florida, United States, 33426
Contact: Sandy DiBattista    561-737-8584 ext 1563    odibattista@entsf.com   
Ear Research Foundation Recruiting
Sarasota, Florida, United States, 34239
Contact: Dishank Patel    941-366-9222 ext 264    dpatel@earrf.org   
United States, Louisiana
Tandem Clinical Research Recruiting
Marrero, Louisiana, United States, 70072
Contact: John Neill    504-934-8424    info@tandemclinicalresearch.com   
United States, Michigan
Michigan Ear Institute Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Deniece Webb    314-268-7407    deniece.webb@health.slu.edu   
United States, New York
Dent Neurologic Institute Recruiting
Amherst, New York, United States, 14226
Contact: Jamie So    716-558-3488    jso@dentinstitute.com   
New York Eye and Ear Infirmary of Mount Sinai Recruiting
New York, New York, United States, 10003
Contact: Samantha Udondem, MPH    212-241-3942    Samantha.udondem@mountsinai.org   
United States, North Carolina
Charlotte Eye Ear Nose & Throat Associates, P.A. Recruiting
Matthews, North Carolina, United States, 28105
Contact    704-295-3390    sennis@ceenta.com   
Piedmont Ear, Nose, and Throat Associates, PA Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Sandra Smith    336-768-3361 ext option 6    ssmith@piedmontent.com   
United States, South Carolina
Medical University of South Carolina, Department of Otolaryngology Recruiting
Charleston, South Carolina, United States, 29425
Contact    843-792-1356      
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Ashudee Kirk, MS    615-936-2491    vbwcresearch@vumc.org   
United States, Utah
Intermountain Ear, Nose & Throat Specialists Recruiting
Draper, Utah, United States, 84020
United States, West Virginia
West Virginia University School of Medicine Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Aimie Jones, CCRC    304-598-6135    jonesai@wvumedicine.org   
Belgium
Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department Recruiting
Edegem, Belgium, 2650
Contact: Julie Moyaert    031 821 5235    Julie.moyaert@uza.be   
UZ Gent - Ear-Nose-Throat Department Recruiting
Gent, Belgium, 9000
Contact: Lara Derycke    003293321246    Lara.derycke@ugent.be   
UZ Leuven - Ear-Nose-Throat Department Recruiting
Leuven, Belgium, 3000
Contact: Christian Desloovere         
CHU de Liège - Ear-Nose-Throat Department Recruiting
Liège, Belgium, 4000
Contact: Severine Camby       s.camby@chuliege.be   
Germany
Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie Recruiting
Aachen, Germany, 52074
Contact: Martin Westhofen    (+49) 241 8089360    mwesthofen@ukaachen.de   
Praxis Bad Essen Recruiting
Bad Essen, Germany, 49152
Contact: T Steinkamp    (+49) 05472 3400    steinkamp@hno-os.de   
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Katharina Stoelzel    (+49) 30 450 555 072    katharina.stoelzel@charite.de   
HNO Zentrum am Kudamm Recruiting
Berlin, Germany, 10629
Contact: Önder Göktas    info@hnozentrum-kudamm.de      
HNO-Praxis Göttingen Recruiting
Göttingen, Germany, 37073
Contact: Detlef Brehmer    0049551 498080    d.brehmer@hno-praxis-goettingen.de   
HNO Praxis am Neckar Recruiting
Heidelberg, Germany, 69120
Contact: Andreas Horn    (+49) 6221401010    horns04@t-online.de   
HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich Recruiting
Heidelberg, Germany, 69126
Contact: F Heimlich    (+49) 06221 -314814    info@praxis-heimlich.de   
Universitätsklinikum Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Angela Schell    0049 621 383 1600    angela.schell@umm.de   
HNO Praxis Dr. med. Roger Fisher Recruiting
Markkleeberg, Germany, 04416
Contact: Roger Fisher    (+49) 0341 3582407    info@hno-markkleeberg.de   
Klinikum der Universität München Recruiting
München, Germany, 81377
Contact: Julia Dlugauczyk       julia.dlugaiczyk@med.uni.muenchen.de   
Italy
U.O. di Otorinolaringoiatria Universitaria Recruiting
Bari, NAP, Italy, 70124
Contact: Nicola Quaranta    (+39) 0805478850    nicolaantonioadolfo.quaranta@uniba.it   
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia Recruiting
Milano, Italy, 20122
Contact: Federica Di Berardino    (+39) 02 5503 3936    federica.diberardino@unimi.it   
Unità Operativa di Otorinolaringoiatria Recruiting
Piacenza, Italy, 29121
Contact: Domenico Cuda    (+39) 0523303262    d.cuda@ausl.pc.it   
Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria Recruiting
Roma, Italy, 00189
Contact: Maurizio Barbara    (+39) 06 33775628    maurizio.barbara@uniroma1.it   
Poland
10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział Recruiting
Bydgoszcz, Poland, 85-681
Contact: Andrzej Krzyzaniak       andrzejkryzaniak@wp.pl   
Centrum Medyczne ZDROWA Recruiting
Kraków, Poland, 31-216
Contact: Katarzyna Zajdel    (+48) 12 3534 546    katarzyna.zajdel@cmzdrowa.pl   
Centrum Medyczne PROMED Recruiting
Kraków, Poland, 31-411
Contact: Agnieszka Łach    (+48) 507110475    alach@cmpromed.pl   
MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński Recruiting
Krosno, Poland, 38-400
Contact: Tomasz Stapiński    (+48) 607223113    t.stapinksi@mtmedic.pl   
Centrum Słuchu i Mowy Sp. z o.o. Recruiting
Nadarzyn, Poland, 05-830
Contact: Kamila Renke    (+48) 22 4635342    badania.kliniczne@csim.pl   
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina Recruiting
Rzeszów, Poland, 35-055
Contact: Wojciech Domka    (+48) 60 5556 026    wdomka@esculap.pl   
ETG Łódź Recruiting
Łódź, Poland, 90-302
Spain
Agencia Pública Empresarial Sanitaria Hospital de Poniente Recruiting
El Ejido, Almería, Spain, 04700
Contact: Manual Gomez Fiñana    +34 671 562 988    manuelsegundo.gomez@ephpo.es   
Hospital Universitario de Getafe Recruiting
Getafe, Madrid, Spain, 28905
Contact: Eduardo Martin Sanz    0034637532038    emartinsanz@gmail.com   
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Juan M. Espinosa    +34 958 89 5476    juanmanuel.espinosa@gmail.com   
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Turkey
Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali Recruiting
Ankara, Turkey, 06100
Contact: Munir Demir Bajin, MD    +90(505)7723547    dbajin@hacettepe.ed.utr   
Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali Recruiting
Istanbul, Turkey, 34093
Contact: Beldon Polat    +90(532)2019140    beldonmdpolat@gmail.com   
Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu Recruiting
Istanbul, Turkey, 34457
Contact: Alper Ozdilek    905335165399    alper.ozdilek@acibadem.com   
Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali Recruiting
İzmir, Turkey, 35100
Contact: Sevine Eraslan    09066359685    sevine.eraslan@hotmail.com   
Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali Recruiting
İzmir, Turkey, 35340
Contact: Enis Alpin Guneri    +90(232)4123251    alpin.guneri@deu.edu.tr   
United Kingdom
Ninewells Hospital and Medical School Recruiting
Dundee, Angus, United Kingdom, DD19SY
Contact: P Spielmann    (+44) 0138 2633899    patrickspielmann@nhs.net   
Contact: P Spielmann    (+44) 01382660111 ext 40228      
Royal Victoria Hospital Recruiting
Belfast, United Kingdom, BT126BA
Contact: Neil Bailie       Neila.Bailie@belfasttrust.hscni.net   
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB20QQ
Contact: Niel Donnelly    (+44) 012 2358 6638    neil.donnelly@addenbrookes.nhs.uk   
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF144XW
Contact: Julia Dolby    (+44) 029 2074 3174    juliadolby@wales.nhs.uk   
Gloucestershire Royal Hospital Recruiting
Gloucester, United Kingdom, GL13NN
Contact: Matthew Clark       matthew.clark11@nhs.net   
University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE15WW
Contact: Adam Lewszuk    (+44)011 6258 5973    clinical.research@uhl-tr.nhs.uk   
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE19RT
Contact: Abigail Tetteh       ENTResearch@gitt.nhs.uk   
Manchester Head and Neck Centre, Peter Mount Building Recruiting
Manchester, United Kingdom, M139WL
Contact: Alice Panes    (+44) 0161 701 1262    alice.panes@mft.nhs.uk   
Norfolk & Norwich University Hospital Recruiting
Norwich, United Kingdom, NR47UY
Contact: Catherine Wright    (+44) 016 0364 6108    catherine.wright@nnuh.nhs.uk   
The Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom, S102JF
Contact: Jayne Wilson    (+44) 0114 271339    jayne.willson@sth.nhs.uk   
Sponsors and Collaborators
Otonomy, Inc.

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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT03664674    
Other Study ID Numbers: 104-201811
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otonomy, Inc.:
Meniere's Disease
Vertigo
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases