Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02997189
Status:
TERMINATED
Last Update Posted:
2020-09-16
First Post:
2016-12-15
Brief Title:
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
Official Title:
A Multicenter Randomized 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
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Negative Efficacy Results from the recently completed Phase 3 study 104-201506
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None