MedTrace Logo

Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment

NCT04262336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-07-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether DB-020 administered via an injection in the middle ear prevents hearing loss in participants who will receive high doses of cisplatin as part of their treatment for cancer.

Conditions

  • Ototoxicity

Interventions

DRUG

DB-020

Injectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water

DRUG

Placebo

Injectable sterile viscous solution of sodium hyaluronate in sodium chloride

Sponsors & Collaborators

  • Decibel Therapeutics

    lead INDUSTRY

Principal Investigators

  • Pablo LaPuerta · Decibel Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-21
Primary Completion
2022-07-30
Completion
2023-05-23
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT04262336 on ClinicalTrials.gov