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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 | Clinical Trials | Clareo Health

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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

NCT03818815•Novus Therapeutics, Inc

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

0 - 2 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female infants and children aged ≥6 months to ≤24 months
•2. 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
•3. Score of 5 or more on the 5 question version of AOM-SOS scale1
•4. 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.
•5. Intact tympanic membrane (TM) in both ears (e.g., no perforation)

Exclusion Criteria

•1. Allergy to penicillin or cephalosporin
•2. History or presence of immunodeficiency disorders
•3. Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1
•4. Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere with Eustachian tube function
•5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
•6. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment

Locations (1)

UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

February 21, 2019

Primary Completion Date

March 9, 2020

Completion Date

March 26, 2020

Last Updated

August 18, 2020

Enrollment

103

ACTUAL participants

Conditions

Acute Otitis Media

Interventions

OP0201

COMBINATION_PRODUCT

Placebo

COMBINATION_PRODUCT

Amoxicillin-clavulanate

DRUG

Analgesic Ear Drops for Children With Acute Otitis Media

NCT05651633

Acute Otitis MediaPain

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UNKNOWN

Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

NCT02591563

Nasopharyngeal Colonization and Acute Otitis Media

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COMPLETEDNA

Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Analgesic Ear Drops for Children With Acute Otitis Media

Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years

Open-Label Study of OTO-201 for Treatment of AOMT

Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children