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
Overview
- Phase
- Phase 2
- Intervention
- OP0201
- Conditions
- Acute Otitis Media
- Sponsor
- Novus Therapeutics, Inc
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Drug: OP0201 + Antibiotics
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Intervention: OP0201
Drug: OP0201 + Antibiotics
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Intervention: Amoxicillin-clavulanate
Placebo Comparator: Placebo +Antibiotics
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Intervention: Placebo
Placebo Comparator: Placebo +Antibiotics
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Intervention: Amoxicillin-clavulanate
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: Days 1-28
Evaluation of Efficacy (Otoscopy)
Time Frame: Day 12
Percentage of study participants with no middle ear effusion