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

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.

Conditions

• Acute Otitis Media

Interventions

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

Sponsors & Collaborators

• Currax Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Steven Goldberg, MD · Visions Clinical Research

• Gerald Shockey, MD · Desert Clinical Research

• Shane Christensen, MD · Foothill Family Clinic South

• Stephanie Plunkett, MD · First Med East

• Katie Julien, MD · Jordan River Family Medcine

• James Peterson, MD · Foothill Family Clinic

• John Ansely, MD · Carolina Ear, Nose and Throat Clinic

• James Hendrick, MD · Kentucky Pediatric and Adult Research

• Amy Agua, MD · Visions Clinical Research Boyton Beach

• Bryan Harvey, MD · Childrens Investigational Research Program

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

2 Months

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• United States

Study Locations