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

NCT02997189 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-09-16

No results posted yet for this study

Summary

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.

Conditions

  • Cisplatin Induced Hearing Loss

Interventions

DRUG

OTO-104

12 mg dexamethasone administered intratympanically

Sponsors & Collaborators

  • Otonomy, Inc.

    lead INDUSTRY

Principal Investigators

  • Kathie Bishop, PhD · Otonomy, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-15
Primary Completion
2017-09-26
Completion
2017-09-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02997189 on ClinicalTrials.gov