Back to resultsA 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
Primary Purpose
Acute Otitis Media
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OP0201
Placebo
Amoxicillin-clavulanate
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Media
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
Sites / Locations
- UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Drug: OP0201 + Antibiotics
Placebo Comparator: Placebo +Antibiotics
Arm Description
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Evaluation of Efficacy (Otoscopy)
Percentage of study participants with no bulging tympanic membrane
Evaluation of Efficacy (Otoscopy)
Percentage of study participants with no middle ear effusion
Secondary Outcome Measures
Full Information
NCT ID
NCT03818815
First Posted
January 22, 2019
Last Updated
August 11, 2020
Sponsor
Novus Therapeutics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03818815
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novus Therapeutics, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug: OP0201 + Antibiotics
Arm Type
Active Comparator
Arm Description
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Arm Title
Placebo Comparator: Placebo +Antibiotics
Arm Type
Placebo Comparator
Arm Description
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Intervention Type
Combination Product
Intervention Name(s)
OP0201
Intervention Description
OP0201 20mg per day in two divided doses for 10 days
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Placebo 0mg per day in two divided doses for 10 days
Intervention Type
Drug
Intervention Name(s)
Amoxicillin-clavulanate
Intervention Description
Oral Amoxicillin-clavulanate in two divided doses for 10 days
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
Days 1-28
Title
Evaluation of Efficacy (Otoscopy)
Description
Percentage of study participants with no bulging tympanic membrane
Time Frame
Day 4
Title
Evaluation of Efficacy (Otoscopy)
Description
Percentage of study participants with no middle ear effusion
Time Frame
Day 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34851411
Citation
Muniz GB, Shope TR, Bhatnagar S, Shaikh N, Haralam MA, Liu H, Martin JM, Pogoda JM, Hoberman A. Intranasal Surfactant for Acute Otitis Media: A Randomized Trial. Pediatrics. 2021 Dec 1;148(6):e2021051703. doi: 10.1542/peds.2021-051703.
Results Reference
derived
Links:
URL
http://novustherapeutics.com/
Description
Related Info
Learn more about this trial
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
We'll reach out to this number within 24 hrs