NCT02092454

Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media

Phase II, Multicenter, Double-Blind, Randomized, Vehicle-Controlled Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Ages 2 Months to 12 Years Presenting With Acute Otitis Media

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Otic Therapy, LLC · Industry
• Sex: All
• Age: 2 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain relief associated with acute otitis media.

Conditions

• Pain
• Acute Otitis Media

Interventions

Type	Name	Description
DRUG	Benzocaine	topical otic solution
DRUG	Placebo	topical otic solution

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-03-20
• Last updated: 2015-05-25

Locations

3 sites across 1 country: United States