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

Acute Otitis Media Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02037893
Study type Interventional
Source Pernix Theraputics LLC
Contact
Status Completed
Phase Phase 2
Start date November 2013
Completion date September 2014
View Details
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