Acute Otitis MediaPhase 2NCT03818815

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

A Phase 2 study testing OP0201 and Amoxicillin-clavulanate in people with Acute Otitis Media, run by Novus Therapeutics, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 6 to 24 months
Conditions the study is for: Acute Otitis Media
What is being tested?: OP0201 and Amoxicillin-clavulanate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 103 participants
Where: 1 siteUnited States
Study dates: 21 Feb 2019to 26 Mar 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 24 months
All sexes
No healthy volunteers
Child

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Conditions: Acute Otitis Media
Being tested: OP0201, Placebo, Amoxicillin-clavulanate
Medical subject headings: Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OP0201Combination product
OP0201 20mg per day in two divided doses for 10 days
PlaceboCombination product
Placebo 0mg per day in two divided doses for 10 days
Amoxicillin-clavulanateDrug
Oral Amoxicillin-clavulanate in two divided doses for 10 days

Study groups in NCT03818815
Study group	Role	What they receive
Drug: OP0201 + Antibiotics	Active comparator	OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days Receives: Combination Product: OP0201; Drug: Amoxicillin-clavulanate
Placebo Comparator: Placebo +Antibiotics	Placebo comparator	Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days Receives: Combination Product: Placebo; Drug: Amoxicillin-clavulanate

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Measured: Days 1-28
Evaluation of Efficacy (Otoscopy)
Percentage of study participants with no bulging tympanic membrane
Measured: Day 4
Evaluation of Efficacy (Otoscopy)
Percentage of study participants with no middle ear effusion
Measured: Day 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 201926 Mar 2020

First posted28 Jan 2019
Study start21 Feb 2019
Primary completion9 Mar 2020
Study completion26 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03818815
Sponsor's protocol ID: OP0201-C-006
Status last verified: Aug 2020
First submitted: 22 Jan 2019
Last updated: 18 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34851411

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Otitis Media trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03818815
Acronym / sponsor ID: OP0201-C-006
Conditions: Acute Otitis Media
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Novus Therapeutics, IncIndustry (pharma, biotech, devices)
Study start: 21 Feb 2019 (actual)
Primary completion: 9 Mar 2020 (actual)
Study completion: 26 Mar 2020 (actual)
First posted: 28 Jan 2019 (actual)
Results: Posted 11 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Drug: OP0201 + Antibiotics	Active comparator	Combination Product: OP0201, Drug: Amoxicillin-clavulanateOP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Placebo Comparator: Placebo +Antibiotics	Placebo comparator	Combination Product: Placebo, Drug: Amoxicillin-clavulanatePlacebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days

Who may qualify

Ages: 6 to 24 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OP0201OP0201 20mg per day in two divided doses for 10 days	Combination product	Drug: OP0201 + Antibiotics
PlaceboPlacebo 0mg per day in two divided doses for 10 days	Combination product	Placebo Comparator: Placebo +Antibiotics
Amoxicillin-clavulanateOral Amoxicillin-clavulanate in two divided doses for 10 days	Drug	Drug: OP0201 + Antibiotics, Placebo Comparator: Placebo +Antibiotics

Primary outcome

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

Results and safety

Results posted to the registry on 11 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drug: OP0201 + Antibiotics	56	48
Placebo Comparator: Placebo +Antibiotics	47	42

Primary outcome: Number of Participants With Adverse Events

Time frame: Days 1-28. Count of participants. Unit: Participants

Measure	Drug: OP0201 + Antibiotics n = 55	Placebo Comparator: Placebo + Antibiotics n = 48
Value	48	36

Population analysed: Subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.

Primary outcome: Evaluation of Efficacy (Otoscopy)

Time frame: Day 4. Number. Unit: Percentage of participants

Measure	Drug: OP0201 + Antibiotics n = 54	Placebo Comparator: Placebo + Antibiotics n = 46
Value	51	47.3

Drug: OP0201 + Antibiotics vs Placebo Comparator: Placebo + Antibiotics: p = 0.62, Regression, Logistic

Population analysed: Subjects who were randomized excluding the first 3 subjects dosed (subject numbers 1001, 1002 and 1003), as there was a known device malfunction for these subjects. Subjects will be summarized and analyzed based on randomization assignment, regardless of treatment received.

Primary outcome: Evaluation of Efficacy (Otoscopy)

Time frame: Day 12. Number. Unit: Percentage of participants

Measure	Drug: OP0201 + Antibiotics n = 54	Placebo Comparator: Placebo + Antibiotics n = 46
Value	55.9	37.9

Drug: OP0201 + Antibiotics vs Placebo Comparator: Placebo + Antibiotics: p = 0.07, Regression, Logistic

Adverse events

Time frame: 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drug: OP0201 + Antibiotics	0 of 55 (0%)	48 of 55 (87.3%)	0 of 55
Placebo Comparator: Placebo + Antibiotics	1 of 48 (2.1%)	36 of 48 (75%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34851411Muniz 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Acute Otitis Media

Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
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Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
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Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OP0201 and Amoxicillin-clavulanate in people with Acute Otitis Media, run by Novus Therapeutics, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Days 1-28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03818815, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.