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

Novus Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acute Otitis Media

Treatments: Combination Product: OP0201; Drug: Amoxicillin-clavulanate; Combination Product: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03818815

OP0201-C-006

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria includes but is not limited to:

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 includes but is not limited to:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 2 patient groups, including a placebo group

Drug: OP0201 + Antibiotics

Active Comparator group

Description:

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

Treatment:

Combination Product: OP0201

Drug: Amoxicillin-clavulanate

Placebo Comparator: Placebo +Antibiotics

Placebo Comparator group

Description:

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

Treatment:

Combination Product: Placebo

Drug: Amoxicillin-clavulanate