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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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ClinicalTrials.gov Identifier: NCT03818815
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Novus Therapeutics, Inc

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.

Condition or disease Intervention/treatment Phase
Acute Otitis Media Drug: OP0201 20mg per day+Amoxicillin-clavulanate Drug: Placebo 0mg per day+Amoxicillin-clavulanate Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Active Comparator: Drug: OP0201 + Antibiotics
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Drug: OP0201 20mg per day+Amoxicillin-clavulanate
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days

Placebo Comparator: Placebo Comparator: Placebo +Antibiotics
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Drug: Placebo 0mg per day+Amoxicillin-clavulanate
Placebo 0mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days




Primary Outcome Measures :
  1. Evaluation of Safety (Adverse Events) [ Time Frame: Days 1-28 ]
  2. Evaluation of Efficacy (Otoscopy) [ Time Frame: Day 4 ]
    Proportion of study participants with bulging tympanic membrane


Secondary Outcome Measures :
  1. Evaluation of Efficacy (Otoscopy) [ Time Frame: Days 4, 12 and 28 ]
    Proportion of study participants with no middle ear effusion

  2. Evaluation of Efficacy (Tympanometry) [ Time Frame: Days 4, 12 and 28 ]
    Proportion of study participants with abnormal tympanogram (Type B or Type C)

  3. Evaluation of Efficacy (AOM-SOS Scale) [ Time Frame: Days 4, 12, and 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) - 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818815


Contacts
Contact: Amy Tran 9492388090 Study006@novustherapeutics.com

Locations
United States, Pennsylvania
UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Alejandro Hoberman, MD    412-692-6000      
Sponsors and Collaborators
Novus Therapeutics, Inc

Additional Information:
Responsible Party: Novus Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT03818815     History of Changes
Other Study ID Numbers: OP0201-C-006
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action