NCT02044341

Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media

A Phase 3, Multicenter, Placebo-controlled, Double-blind, Randomized Study to Compare the Efficacy and Safety of AR01 Otic Solution to a Placebo Solution for Relief of Pain in Acute Otitis Media Subjects Aged 2 Months to 19 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Arbor Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 2 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The patient or caregiver will measure the amount of ear pain before and after the ear drops to establish if the medicated ear drops decrease the amount of pain more than the placebo ear drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be used up to 4 days, as needed for ear pain.

Detailed description

The study involves the initial clinic visit, using the ear drops at home and keeping a diary about the ear pain experienced and medications taken. The patient will return to the clinic 4 days later for evaluation and to return the ear drops and diary. The clinic staff will call to follow-up about the patient's condition seven days after the initial visit.

Conditions

• Acute Otitis Media

Interventions

Type	Name	Description
DRUG	AR01	drops administered an needed for pain
DRUG	Glycerin ear drops	placebo drops administered for ear pain

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-01-24
• Last updated: 2015-04-08

Locations

29 sites across 1 country: United States