Status:
COMPLETED
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
Lead Sponsor:
Novus Therapeutics, Inc
Conditions:
Acute Otitis Media
Eligibility:
All Genders
6-24 years
Phase:
PHASE2
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 Otit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2020
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03818815
Start Date
February 21 2019
End Date
March 26 2020
Last Update
August 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building
Pittsburgh, Pennsylvania, United States, 15213