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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2020-08-18

Study results available
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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.

Conditions

  • Acute Otitis Media

Interventions

COMBINATION_PRODUCT

OP0201

OP0201 20mg per day in two divided doses for 10 days

COMBINATION_PRODUCT

Placebo

Placebo 0mg per day in two divided doses for 10 days

DRUG

Amoxicillin-clavulanate

Oral Amoxicillin-clavulanate in two divided doses for 10 days

Sponsors & Collaborators

  • Novus Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-21
Primary Completion
2020-03-09
Completion
2020-03-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03818815 on ClinicalTrials.gov