NCT03818815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

February 21, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 11, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

January 22, 2019

Results QC Date

July 1, 2020

Last Update Submit

August 11, 2020

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Adverse Events

    Days 1-28

  • Evaluation of Efficacy (Otoscopy)

    Percentage of study participants with no bulging tympanic membrane

    Day 4

  • Evaluation of Efficacy (Otoscopy)

    Percentage of study participants with no middle ear effusion

    Day 12

Study Arms (2)

Drug: OP0201 + Antibiotics

ACTIVE COMPARATOR

OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days

Combination Product: OP0201Drug: Amoxicillin-clavulanate

Placebo Comparator: Placebo +Antibiotics

PLACEBO COMPARATOR

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

Combination Product: PlaceboDrug: Amoxicillin-clavulanate

Interventions

OP0201COMBINATION_PRODUCT

OP0201 20mg per day in two divided doses for 10 days

Drug: OP0201 + Antibiotics
PlaceboCOMBINATION_PRODUCT

Placebo 0mg per day in two divided doses for 10 days

Placebo Comparator: Placebo +Antibiotics
Amoxicillin-clavulanateDRUG

Oral Amoxicillin-clavulanate in two divided doses for 10 days

Drug: OP0201 + AntibioticsPlacebo Comparator: Placebo +Antibiotics

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • 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.

    PMID: 34851411DERIVED

Related Links

MeSH Terms

Conditions

Otitis Media

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Clinical Director
Organization
Novus Therapeutics
study006@novustherapeutics.com
949-679-1110

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 28, 2019

Study Start

February 21, 2019

Primary Completion

March 9, 2020

Study Completion

March 26, 2020

Last Updated

August 18, 2020

Results First Posted

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)