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
Phase 2
Completed
- Conditions
- Acute Otitis Media
- Interventions
- Combination Product: OP0201Combination Product: PlaceboDrug: Amoxicillin-clavulanate
- Registration Number
- NCT03818815
- Lead Sponsor
- Novus Therapeutics, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug: OP0201 + Antibiotics OP0201 OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days Placebo Comparator: Placebo +Antibiotics Amoxicillin-clavulanate Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days Drug: OP0201 + Antibiotics Amoxicillin-clavulanate OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days Placebo Comparator: Placebo +Antibiotics Placebo Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events Days 1-28 Evaluation of Efficacy (Otoscopy) Day 12 Percentage of study participants with no middle ear effusion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building
🇺🇸Pittsburgh, Pennsylvania, United States