NCT02037893

Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media

A Four-arm, Randomized, Double-blind, Active and Placebo Controlled Study to Determine the Safety and Efficacy of a Combination Antipyrine and Benzocaine Otic Solution Compared With Antipyrine Otic Solution Alone, Benzocaine Otic Solution Alone and to Placebo Otic Solution to Relieve Pain Symptoms in Children With Acute Otitis Media.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Currax Pharmaceuticals · Industry
• Sex: All
• Age: 2 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.

Detailed description

Reduction of pain symptoms will be measured by using the Face, Legs, Activity, Cry, Consolability Scale (FLACC) and the Faces pain Scale Revised (FPS-R).

Conditions

• Acute Otitis Media

Interventions

Type	Name	Description
DRUG	Antipyrine and Benzocaine otic solution	antipyrine 54 mg and benzocaine 14 mg
DRUG	Antipyrine Otic Solution	Antipyrine 54 mg and glycerine dehydrated to 1.0 mL
DRUG	Benzocaine Otic Solution	benzocaine 14 mg and glycerine dehydrated to 1.0 mL
DRUG	Placebo Otic solution	Placebo otic solution will be glycerin that is dehydrated

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-01-16
• Last updated: 2024-08-07
• Results posted: 2018-08-31

Locations

10 sites across 1 country: United States