Phase 1
Completed N=24
Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media
Source: ClinicalTrials.gov NCT03766373 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 2; 6 Participants
Summary
The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
2; 6 | — |
Eligibility Criteria
Inclusion Criteria includes but is not limited to:
- AOM diagnosis with moderate to severe bulging of the TM and recent ( 2 h are permitted as long as ear pain criteria are met per Inclusion Criteria)
Data sourced from ClinicalTrials.gov (NCT03766373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.