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

NCT ID: NCT02037893

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Antipyrine and Benzocaine Otic solution

antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Group Type: EXPERIMENTAL

Antipyrine and Benzocaine otic solution

Intervention Type: DRUG

antipyrine 54 mg and benzocaine 14 mg

Placebo Otic solution

Intervention Type: DRUG

Placebo otic solution will be glycerin that is dehydrated

Antipyrine Otic Solution

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Group Type: ACTIVE_COMPARATOR

Antipyrine Otic Solution

Intervention Type: DRUG

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution

Intervention Type: DRUG

Placebo otic solution will be glycerin that is dehydrated

Benzocaine Otic Solution

benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Group Type: ACTIVE_COMPARATOR

Benzocaine Otic Solution

Intervention Type: DRUG

benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Placebo Otic solution

Intervention Type: DRUG

Placebo otic solution will be glycerin that is dehydrated

Placebo

Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Group Type: PLACEBO_COMPARATOR

Placebo Otic solution

Intervention Type: DRUG

Placebo otic solution will be glycerin that is dehydrated

Interventions

Antipyrine and Benzocaine otic solution

antipyrine 54 mg and benzocaine 14 mg

Intervention Type: DRUG

Antipyrine Otic Solution

Antipyrine 54 mg and glycerine dehydrated to 1.0 mL

Intervention Type: DRUG

Benzocaine Otic Solution

benzocaine 14 mg and glycerine dehydrated to 1.0 mL

Intervention Type: DRUG

Placebo Otic solution

Placebo otic solution will be glycerin that is dehydrated

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical Diagnosis of Acute Otitis Media
• Moderate to severe pain
• Normally active and in good health as determined by the PI
• Parent or legal guardian consent
• Caregiver available to complete diaries during study

Exclusion Criteria

• History of or current Perforated tympanic membrane
• Tympanostomy tubes
• Acute or chronic otitis externa
• seborrheic dermatitis
• Received any otic topical or systemic antibiotic within 14 days of enrollment
• Receiving medication on a chronic basis for pain
• Known hypersensitivity to investigational product.
• clinical significant mental illness as determined by the PI
• Exposed to another investigational agent within 30 days before study entry. Any condition the PI believed will interfere with the ability to comply with all study procedures
• History of glucose 6-phosphate dehydrogenase deficiency
• History or currently anemic
• Congenital methemoglobinemia
• Recent history of acute gastroenteritis within 14 days of enrollment

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Currax Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Visions Clinical Research

Gerald Shockey, MD

Role: PRINCIPAL_INVESTIGATOR

Desert Clinical Research

Shane Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

Foothill Family Clinic South

Stephanie Plunkett, MD

Role: PRINCIPAL_INVESTIGATOR

First Med East

Katie Julien, MD

Role: PRINCIPAL_INVESTIGATOR

Jordan River Family Medcine

James Peterson, MD

Role: PRINCIPAL_INVESTIGATOR

Foothill Family Clinic

John Ansely, MD

Role: PRINCIPAL_INVESTIGATOR

Carolina Ear, Nose and Throat Clinic

James Hendrick, MD

Role: PRINCIPAL_INVESTIGATOR

Kentucky Pediatric and Adult Research

Amy Agua, MD

Role: PRINCIPAL_INVESTIGATOR

Visions Clinical Research Boyton Beach

Bryan Harvey, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Investigational Research Program

Locations

Desert Clinical Research

Mesa, Arizona, United States

Visions Clinical Research

Tucson, Arizona, United States

Childrens Investigational Research Program

Bentonville, Arkansas, United States

Visions Clinical Research

Boynton Beach, Florida, United States

Kentucky Pediatric and Adult Research

Bardstown, Kentucky, United States

Carolina Ear, Nose and Throat Clinic

Orangeburg, South Carolina, United States

Foothill Family Clinic

Salt Lake City, Utah, United States

FirstMed East

Salt Lake City, Utah, United States

Foothill Family Clinic South

Salt Lake City, Utah, United States

Jordan River Family Medicine

South Jordan, Utah, United States

Countries

United States

Other Identifiers

PNX-CL-001

Identifier Type: -

Identifier Source: org_study_id