Phase 2
N=103
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
Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT03818815 ↗Enrolled (actual)
103
Serious AEs
1.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants With Adverse Events — 48; 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OP0201 (Combination_product); Placebo (Combination_product); Amoxicillin-clavulanate (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novus Therapeutics, Inc
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
48; 36 | — |
| PRIMARY Evaluation of Efficacy (Otoscopy) |
55.9; 37.9 | 0.07 |
| PRIMARY Evaluation of Efficacy (Otoscopy) |
55.9; 37.9 | 0.07 |
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.
Eligibility Criteria
Inclusion Criteria includes but is not limited to:
- Male and female infants and children aged ≥6 months to ≤24 months
- 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
- Score of 5 or more on the 5 question version of AOM-SOS scale1
- 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.
- Intact tympanic membrane (TM) in both ears (e.g., no perforation)
Exclusion Criteria includes but is not limited to:
- Allergy to penicillin or cephalosporin
- History or presence of immunodeficiency disorders
- Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1
- Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere with Eustachian tube function
- Disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
- Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
Data sourced from ClinicalTrials.gov (NCT03818815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.