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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Currax Pharmaceuticals; Pernix Theraputics LLC
• Treatments: Antipyrine; Benzocaine; Pharmaceutical Solutions

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