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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.

Official Title
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Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media

Conditions
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Acute Otitis Media

Intervention / Treatment
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* Combination Product: Drug: OP0201 20mg
* Combination Product: Drug: Placebo 0mg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug: OP0201<br> | Combination Product: Drug: OP0201 20mg<br>* OP0201<br>|
| Placebo Comparator: Drug: Placebo<br> | Combination Product: Drug: Placebo 0mg<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | 1 Day |