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 Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2020-03-26

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.

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Detailed Description

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Conditions

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Acute Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Drug: OP0201 + Antibiotics

OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days

Group Type ACTIVE_COMPARATOR

OP0201

Intervention Type COMBINATION_PRODUCT

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

Amoxicillin-clavulanate

Intervention Type DRUG

Oral Amoxicillin-clavulanate in two divided doses for 10 days

Placebo Comparator: Placebo +Antibiotics

Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

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

Amoxicillin-clavulanate

Intervention Type DRUG

Oral Amoxicillin-clavulanate in two divided doses for 10 days

Interventions

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OP0201

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

Intervention Type COMBINATION_PRODUCT

Placebo

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

Intervention Type COMBINATION_PRODUCT

Amoxicillin-clavulanate

Oral Amoxicillin-clavulanate in two divided doses for 10 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No