Phase 1 N=24 Randomized Quadruple-blind Other

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

Acute Otitis Media

Bottom Line

View on ClinicalTrials.gov: NCT03766373 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Number of Participants With Adverse Events — 2; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Drug: OP0201 20mg (Combination_product); Drug: Placebo 0mg (Combination_product)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novus Therapeutics, Inc
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	2; 6	—

Summary

The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.

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)

View full record on ClinicalTrials.gov →

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.