Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria includes but is not limited to:
AOM diagnosis with moderate to severe bulging of the TM and recent (< 48 hours [h]) onset of ear pain.
Moderate to severe ear pain in the affected ear(s), defined as a score of ≥ 5 (on a scale of 0 10) on the NRS 11 as evaluated by the subject at Screening.
Generally good health (other than AOM) as determined by evaluation of medical history and physical examination at Screening.
Negative urine pregnancy test at Screening for all female subjects of childbearing potential.
Able to read and sign written informed consent prior to study participation.
Exclusion Criteria includes but is not limited to:
Presence of a perforated TM at Screening or had a perforated TM within 6 months (mo) prior to Screening as determined by medical history
Subjects with tympanostomy tubes
Acute or chronic otitis externa
Chronic otitis media defined as confirmed presence of middle ear effusion for 12 weeks or longer
Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
Permanent hearing loss irrespective of otitis media
Subjects with medical conditions that may affect interpretation of the safety or efficacy of study drug as determined by the investigator's medical judgment
Subjects with craniofacial abnormalities (eg, cleft palate, Down's Syndrome)
Subjects with erythema of the TM without other evidence of otitis media
Seborrheic dermatitis involving the affected external ear canal or pinna
Use of medications with known vasoconstrictive properties (eg, decongestants [Afrin®, Sudafed®]) currently or within 2 h prior to Screening
Use of oral analgesics < 2 h prior to Screening or Baseline (oral analgesics > 2 h are permitted as long as ear pain criteria are met per Inclusion Criteria)