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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818815
• Other study ID #: OP0201-C-006
• Status: Completed
• Phase: Phase 2
• Start date: February 21, 2019
• Est. completion date: March 26, 2020

Study information

• Verified date: August 2020
• Source: Novus Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 26, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria includes but is not limited to:

1. Male and female infants and children aged =6 months to =24 months

2. 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

3. Score of 5 or more on the 5 question version of AOM-SOS scale1

4. 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.

5. Intact tympanic membrane (TM) in both ears (e.g., no perforation)

Exclusion Criteria includes but is not limited to:

1. Allergy to penicillin or cephalosporin

2. History or presence of immunodeficiency disorders

3. Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1

4. Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere with Eustachian tube function

5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)

6. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Combination Product:
• OP0201
OP0201 20mg per day in two divided doses for 10 days
• 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

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novus Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events		Days 1-28
Primary	Evaluation of Efficacy (Otoscopy)	Percentage of study participants with no bulging tympanic membrane	Day 4
Primary	Evaluation of Efficacy (Otoscopy)	Percentage of study participants with no middle ear effusion	Day 12

External Links

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