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

PHASE3CompletedINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

August 27, 2018

Primary Completion Date

December 22, 2020

Study Completion Date

December 22, 2020

Conditions
Meniere Disease
Interventions
DRUG

OTO-104

Single intratympanic injection of 12 mg dexamethasone

DRUG

Placebo

Single intratympanic injection of placebo

Trial Locations (65)

2650

Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department, Edegem

3000

UZ Leuven - Ear-Nose-Throat Department, Leuven

4000

CHU de Liège - Ear-Nose-Throat Department, Liège

9000

UZ Gent - Ear-Nose-Throat Department, Ghent

10003

New York Eye and Ear Infirmary of Mount Sinai, New York

10117

Charité Universitätsmedizin Berlin, Berlin

10629

HNO Zentrum am Kudamm, Berlin

14226

Dent Neurologic Institute, Amherst

16059

Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali, Bursa

18014

Hospital Universitario Virgen de las Nieves, Granada

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia, Milan

26506

West Virginia University School of Medicine, Morgantown

27103

Piedmont Ear, Nose, and Throat Associates, PA, Winston-Salem

28105

Charlotte Eye Ear Nose & Throat Associates, P.A., Matthews

28905

Hospital Universitario de Getafe, Getafe

29121

Unità Operativa di Otorinolaringoiatria, Piacenza

29425

Medical University of South Carolina, Department of Otolaryngology, Charleston

33426

Ear, Nose and Throat Associates of South Florida, Boynton Beach

34093

Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali, Istanbul

34239

Ear Research Foundation, Sarasota

34457

Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu, Istanbul

35100

Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali, Izmir

35340

Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali, Izmir

37073

HNO-Praxis Göttingen, Göttingen

37232

Vanderbilt University Medical Center, Nashville

41009

Hospital Universitario Virgen Macarena, Seville

48334

Michigan Ear Institute, Farmington Hills

49152

Praxis Bad Essen, Bad Essen

52074

Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie, Aachen

63110

Saint Louis University, St Louis

68167

Universitätsklinikum Mannheim, Mannheim

69120

HNO Praxis am Neckar, Heidelberg

69126

HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich, Heidelberg

70072

Tandem Clinical Research, Marrero

70124

U.O. di Otorinolaringoiatria Universitaria, Bari

80045

University of Colorado School of Medicine, Aurora

80909

Colorado ENT & Allergy, Colorado Springs

81377

Klinikum der Universität München, München

84020

Intermountain Ear, Nose & Throat Specialists, Draper

89075

Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie, Ulm

93720

Central California Clinical Research, Fresno

06510

Yale University School of Medicine, New Haven

04416

HNO Praxis Dr. med. Roger Fisher, Markkleeberg

00189

Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria, Roma

85-681

10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział, Bydgoszcz

31-216

Centrum Medyczne ZDROWA, Krakow

31-411

Centrum Medyczne PROMED, Krakow

38-400

MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński, Krosno

90-302

ETG Łódź, Lodz

05-830

Centrum Słuchu i Mowy Sp. z o.o., Nadarzyn

35-055

Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina, Rzeszów

04700

Agencia Pública Empresarial Sanitaria Hospital de Poniente, El Ejido

06100

Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali, Ankara

06490

Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali, Ankara

06530

Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu, Ankara

DD19SY

Ninewells Hospital and Medical School, Dundee

BT126BA

Royal Victoria Hospital, Belfast

CB20QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

CF144XW

University Hospital of Wales, Cardiff

GL13NN

Gloucestershire Royal Hospital, Gloucester

LE15WW

University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary, Leicester

SE19RT

Guy's and St Thomas' NHS Foundation Trust, London

M139WL

Manchester Head and Neck Centre, Peter Mount Building, Manchester

NR47UY

Norfolk & Norwich University Hospital, Norwich

S102JF

The Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Otonomy, Inc.

INDUSTRY