A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

Study Overview
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Brief Summary
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The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.

Official Title
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A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

Conditions
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Acute Otitis Media

Intervention / Treatment
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* Combination Product: OP0201
* Combination Product: Placebo
* Drug: Amoxicillin-clavulanate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria includes but is not limited to: Male and female infants and children aged ≥6 months to ≤24 months Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild bulging of TM and recent [less than 48 hours] onset of ear pain or intense erythema of the TM Score of 5 or more on the 5 question version of AOM-SOS scale1 Written informed consent by the child's legal guardian and their willingness to ensure that study instructions are followed, all study-related visits are attended, that treatment administration is given, and Parent/Caregiver assessments are recorded according to the study protocol. Intact tympanic membrane (TM) in both ears (e.g., no perforation) Exclusion Criteria includes but is not limited to: Allergy to penicillin or cephalosporin History or presence of immunodeficiency disorders Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1 Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere with Eustachian tube function Disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug: OP0201 + Antibiotics<br>OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days | Combination Product: OP0201<br>* OP0201 20mg per day in two divided doses for 10 days<br>Drug: Amoxicillin-clavulanate<br>* Oral Amoxicillin-clavulanate in two divided doses for 10 days<br>|
| Placebo Comparator: Placebo Comparator: Placebo +Antibiotics<br>Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days | Combination Product: Placebo<br>* Placebo 0mg per day in two divided doses for 10 days<br>Drug: Amoxicillin-clavulanate<br>* Oral Amoxicillin-clavulanate in two divided doses for 10 days<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 |  | Days 1-28 | 
| Evaluation of Efficacy (Otoscopy) | Percentage of study participants with no bulging tympanic membrane | Day 4 | 
| Evaluation of Efficacy (Otoscopy) | Percentage of study participants with no middle ear effusion | Day 12 |