Trial · NCT03818815

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

NCT03818815, Phase 2, Completed, Novus Therapeutics, Inc; results first posted 2020-08-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT03818815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03818815

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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
NCT number: NCT03818815
Status: Completed
Phases: Phase 2
Enrollment: 103 participants, actual
Lead sponsor: Novus Therapeutics, Inc
Conditions: Acute Otitis Media
Interventions: OP0201, Placebo, Amoxicillin-clavulanate
First posted: 2019-01-28
Last updated: 2020-08-18
Results first posted: 2020-08-11

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events	Days 1-28	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.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Evaluation of Efficacy (Otoscopy)	Day 4	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.	Percentage of participants	NUMBER
PRIMARY	Evaluation of Efficacy (Otoscopy)	Day 12	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.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Adverse Events	Drug: OP0201 + Antibiotics	48	Participants
Number of Participants With Adverse Events	Placebo Comparator: Placebo + Antibiotics	36	Participants
Evaluation of Efficacy (Otoscopy)	Drug: OP0201 + Antibiotics	51	Percentage of participants
Evaluation of Efficacy (Otoscopy)	Placebo Comparator: Placebo + Antibiotics	47.3	Percentage of participants
Evaluation of Efficacy (Otoscopy)	Drug: OP0201 + Antibiotics	55.9	Percentage of participants
Evaluation of Efficacy (Otoscopy)	Placebo Comparator: Placebo + Antibiotics	37.9	Percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Drug: OP0201 + Antibiotics	56
Overall Study	STARTED	Placebo Comparator: Placebo +Antibiotics	47
Overall Study	COMPLETED	Drug: OP0201 + Antibiotics	48
Overall Study	COMPLETED	Placebo Comparator: Placebo +Antibiotics	42
Overall Study	NOT COMPLETED	Drug: OP0201 + Antibiotics	8
Overall Study	NOT COMPLETED	Placebo Comparator: Placebo +Antibiotics	5

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Drug: OP0201 + Antibiotics	24	55	24
other	Diarrhoea	Gastrointestinal disorders	Placebo Comparator: Placebo + Antibiotics	22	48	23
other	Vomiting	Gastrointestinal disorders	Drug: OP0201 + Antibiotics	6	55	6
other	Vomiting	Gastrointestinal disorders	Placebo Comparator: Placebo + Antibiotics	4	48	4
other	Pyrexia	General disorders	Drug: OP0201 + Antibiotics	3	55	3
other	Pyrexia	General disorders	Placebo Comparator: Placebo + Antibiotics	1	48	1
other	Upper Respiratory Tract Infection	Infections and infestations	Drug: OP0201 + Antibiotics	5	55	5
other	Upper Respiratory Tract Infection	Infections and infestations	Placebo Comparator: Placebo + Antibiotics	2	48	2
other	Cough	Respiratory, thoracic and mediastinal disorders	Drug: OP0201 + Antibiotics	3	55	3
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo Comparator: Placebo + Antibiotics	2	48	2

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Drug: OP0201 + Antibiotics	0	55
Total, all-cause mortality	Placebo Comparator: Placebo + Antibiotics	0	48
Total, other adverse events	Drug: OP0201 + Antibiotics	48	55
Total, other adverse events	Placebo Comparator: Placebo + Antibiotics	36	48
Total, serious adverse events	Drug: OP0201 + Antibiotics	0	55
Total, serious adverse events	Placebo Comparator: Placebo + Antibiotics	1	48

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34851411	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Drug: OP0201 + Antibiotics vs Placebo Comparator: Placebo + Antibiotics: Number of Participants With Adverse Events	Trial comparisons
Drug: OP0201 + Antibiotics vs Placebo Comparator: Placebo + Antibiotics: deaths from any cause	Trial comparisons
Drug: OP0201 + Antibiotics vs Placebo Comparator: Placebo + Antibiotics: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03818815

GET https://conductscience.org/api/trials/v1/NCT03818815/events?page=2

API reference For AI assistants