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

Currax Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acute Otitis Media

Treatments: Drug: Benzocaine Otic Solution; Drug: Placebo Otic solution; Drug: Antipyrine and Benzocaine otic solution; Drug: Antipyrine Otic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02037893

PNX-CL-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 112 patients

Sex: All

Ages: 2 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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112 participants in 4 patient groups, including a placebo group

Antipyrine and Benzocaine Otic solution

Experimental group

Description:

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

Treatment:

Drug: Antipyrine and Benzocaine otic solution

Drug: Placebo Otic solution

Antipyrine Otic Solution

Active Comparator group

Description:

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

Treatment:

Drug: Antipyrine Otic Solution

Drug: Placebo Otic solution

Benzocaine Otic Solution

Active Comparator group

Description:

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

Treatment:

Drug: Placebo Otic solution

Drug: Benzocaine Otic Solution

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Otic solution