NCT02997189 is a Phase 2 clinical trial of OTO-104 in Cisplatin Induced Hearing Loss, sponsored by Otonomy, Inc..

Who is sponsoring NCT02997189?

NCT02997189 is sponsored by Otonomy, Inc..

What drugs are being tested in NCT02997189?

Interventions in NCT02997189: OTO-104.

What condition does NCT02997189 study?

NCT02997189 studies Cisplatin Induced Hearing Loss.

Is NCT02997189 still recruiting?

NCT02997189 is currently terminated. Last updated 16 September 2020.

Last reviewed 2020-09-16 · How we verify

NCT02997189

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss

Terminated Phase 2 Last updated 16 September 2020

What this trial tests

Phase 2 trial testing OTO-104 in Cisplatin Induced Hearing Loss in 12 participants. Terminated before completion.

Timeline

15 November 2016

Primary endpoint
26 September 2017

26 September 2017

Quick facts

Lead sponsor	Otonomy, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	12
Start date	15 November 2016
Primary completion	26 September 2017
Estimated completion	26 September 2017
Sites	1 location across United States

Drugs / interventions tested

OTO-104 — full drug profile →

Conditions studied

Cisplatin Induced Hearing Loss — all drugs for Cisplatin Induced Hearing Loss →

Sponsor

Otonomy, Inc. — full company profile →

Who can join

Adults 6 Months to 21, any sex, with Cisplatin Induced Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Progress in the Development of Preventative Drugs for Cisplatin-Induced Hearing Loss.
Hazlitt RA, Min J, Zuo J. · · 2018 · cited 77× · PMID 29361217 · DOI 10.1021/acs.jmedchem.7b01653
Strategies to reduce the risk of platinum containing antineoplastic drug-induced ototoxicity.
Mukherjea D, Dhukhwa A, Sapra A, Bhandari P, et al · · 2020 · cited 27× · PMID 32757852 · DOI 10.1080/17425255.2020.1806235
Investigational Medicinal Products for the Inner Ear: Review of Clinical Trial Characteristics in ClinicalTrials.gov.
Le Prell CG. · · 2021 · cited 18× · PMID 35609594 · DOI 10.1055/s-0041-1735522
Medical interventions for the prevention of platinum-induced hearing loss in children with cancer.
van As JW, van den Berg H, van Dalen EC. · · 2019 · cited 13× · PMID 31063591 · DOI 10.1002/14651858.cd009219.pub5
Rethinking neurocognitive outcomes in adult survivors of childhood medulloblastoma: Progress and unmet challenges.
Liu S, Ma J. · · 2025 · PMID 40296361 · DOI 10.1093/neuonc/noaf051
Feasibility and Safety of Intratympanic Administration of Sustained-Exposure Dexamethasone Thermosensitive Gel (OTO-104) for Prevention of Cisplatin-Induced Hearing Loss in Children: A Multisite Phase 2 Randomized Clinical Trial.
Freyer DR, Ohlsen TJD, Don D, Orgel E, et al · · 2025 · PMID 40128126 · DOI 10.1002/pbc.31680
Molecular Characteristics of Cisplatin-Induced Ototoxicity and Therapeutic Interventions
Tan W, Vlajkovic S. · · 2023

Verify or expand the search:

Other trials of OTO-104

Trials testing the same drug.

NCT03664674 — Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease · Phase 3 · completed
NCT02717442 — Study of OTO-104 in Subjects With Unilateral Meniere's Disease · Phase 3 · terminated
NCT02612337 — Study of OTO-104 in Subjects With Unilateral Meniere's Disease · Phase 3 · completed

Other Otonomy, Inc. trials

Trials by the same sponsor.

NCT04829214 — OTO-313 in Subjects With Unilateral Subjective Tinnitus · Phase 2 · completed
NCT04129775 — OTO-413 in Subjects With Speech-in-Noise Hearing Impairment · Phase 1, PHASE2 · completed
NCT03918109 — OTO-313 in Subjects With Subjective Tinnitus · Phase 1, PHASE2 · completed
NCT03664674 — Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease · Phase 3 · completed
NCT02717442 — Study of OTO-104 in Subjects With Unilateral Meniere's Disease · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02997189 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otonomy, Inc.
Last refreshed: 16 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02997189.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing