Trials / Completed
CompletedNCT03818815
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Novus Therapeutics, Inc · Industry
- Sex
- All
- Age
- 6 Months – 24 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-02-21
- Primary completion
- 2020-03-09
- Completion
- 2020-03-26
- First posted
- 2019-01-28
- Last updated
- 2020-08-18
- Results posted
- 2020-08-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03818815. Inclusion in this directory is not an endorsement.