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NCT04262336 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment
A Phase 1 study of Ototoxicity, sponsored by Decibel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 8
- Study locations
NCT04262336: Completed Phase 1 study of Ototoxicity, sponsored by Decibel Therapeutics.
NCT04262336 is a Phase 1 study of Ototoxicity that has completed, run by Decibel Therapeutics. The registered enrollment target is 22 participants, below the 153-participant average among 3 other Ototoxicity trials with a reported enrollment target (86% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04262336, a Phase 1 study of Ototoxicity, has completed, sponsored by Decibel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
To investigate the safety and tolerability of DB-020 when given intratympanically to patients receiving cisplatin chemotherapy treatment
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DB-020
Study Locations (8)
Victoria
- Peter MacCallum Cancer Centre - Melbourne
- Oncology and Palliative Care Research - Melbourne
Florida
- University of Miami Health System - Miami
Kansas
- University of Kansas Medical Center - Kansas City
New York
- Northwell Health Cancer Center - Lake Success
West Virginia
- WVU Cancer Institute - Morgantown
Queensland
- Queensland Head and Neck Cancer Centre - Woolloongabba
Western Australia
- Fiona Stanley Hospital, Clinical Trials Unit Cancer Center - Murdoch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-02-21 |
| Est. Completion | 2023-05-23 |
| Phase | Phase 1 |
What the finished NCT04262336 record still lists
NCT04262336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 153-participant average among 3 other Ototoxicity trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Ototoxicity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04262336 lists 8 locations in 7 states (Victoria, Florida, Kansas).
Frequently Asked Questions
What is clinical trial NCT04262336 about?
NCT04262336 is a clinical study titled "Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment". 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.
What is the current status of trial NCT04262336?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2020-02-21. Estimated completion is 2023-05-23.
What conditions does trial NCT04262336 study?
This clinical trial studies the following conditions: Ototoxicity.
What interventions are being tested in trial NCT04262336?
The interventions under investigation include: Placebo (DRUG), DB-020 (DRUG).
Who is sponsoring clinical trial NCT04262336?
This trial is sponsored by Decibel Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04262336 being conducted?
This trial has 8 study locations across Florida, Kansas, New York, West Virginia, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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