For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

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)
  3. 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
  4. Score of 5 or more on the 5 question version of AOM-SOS scale1
  5. 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.
  6. 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
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 9492388090Email iconEmail Study Center

Study’s details


Contition

Acute Otitis Media

Age

6+

Phase

Phase 2

Participants needed

103

Est. Completion Date

Mar 2020

Treatment type

Interventional


Sponsor

Novus Therapeutics, Inc

ClinicalTrials.gov identifier

NCT03818815

Study number

OP0201-C-006

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