NCT04129775: An overdue trial by Otonomy, Inc.
This trial is overdue. It was due to report 2 years, 3 months ago.
Think we've made a mistake? Before contacting us, review the criteria in our paper. In particular, bear in mind the following:
- We can only rely on the structured data that sponsors put into the registry: they may enter incorrect or incomplete data.
- Reporting in a journal is not enough. The FDAAA rules state that the trial must be reported on ClinicalTrials.gov.
- Terminated trials are required to report results. Only withdrawn trials (which never recruited a single patient) are not.
Full data
| Full entry on ClinicalTrials.gov | NCT04129775 |
|---|---|
| Title | A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-noise Hearing Impairment |
| Results Status | Overdue |
| ACT or pACT? | This is what FDAAA officially calls an "Applicable Clinical Trial" |
| Start date | Oct. 1, 2019 |
| Completion date | Sept. 5, 2022 |
| Required reporting date | Sept. 5, 2023, midnight |
| Actual reporting date | None |
| Date last checked at ClinicalTrials.gov | Dec. 12, 2025 |
| Days late | 829 |