Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
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.