Trial · NCT03766373

Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media

NCT03766373, Phase 1, Completed, Novus Therapeutics, Inc; results first posted 2019-11-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media. Trials, record NCT03766373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03766373

On this page

Trial

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

Title: Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media
NCT number: NCT03766373
Status: Completed
Phases: Phase 1
Enrollment: 24 participants, actual
Lead sponsor: Novus Therapeutics, Inc
Conditions: Acute Otitis Media
Interventions: Drug: OP0201 20mg, Drug: Placebo 0mg
First posted: 2018-12-06
Last updated: 2019-12-05
Results first posted: 2019-11-21

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events	1 Day

Source ClinicalTrials.gov

Outcomes1

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	1 Day		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Adverse Events	Drug: OP0201		2		Participants
Number of Participants With Adverse Events	Drug: Placebo		6		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	12
Overall Study	STARTED	Drug: Placebo	12
Overall Study	COMPLETED	Drug: OP0201	12
Overall Study	COMPLETED	Drug: Placebo	12
Overall Study	NOT COMPLETED	Drug: OP0201	0
Overall Study	NOT COMPLETED	Drug: Placebo	0

Source ClinicalTrials.gov

Adverse events16

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	Lacrimation increased	Eye disorders	Drug: OP0201	1	12	1
other	Lacrimation increased	Eye disorders	Drug: Placebo	0	12	0
other	Feeling cold	Gastrointestinal disorders	Drug: OP0201	0	12	0
other	Feeling cold	Gastrointestinal disorders	Drug: Placebo	1	12	1
other	Dizziness	Nervous system disorders	Drug: OP0201	0	12	0
other	Dizziness	Nervous system disorders	Drug: Placebo	1	12	1
other	Headache	Nervous system disorders	Drug: OP0201	0	12	0
other	Headache	Nervous system disorders	Drug: Placebo	1	12	1
other	Nasal discomfort	Respiratory, thoracic and mediastinal disorders	Drug: OP0201	1	12	1
other	Nasal discomfort	Respiratory, thoracic and mediastinal disorders	Drug: Placebo	2	12	2

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Drug: OP0201	0	12
Total, all-cause mortality	Drug: Placebo	0	12
Total, other adverse events	Drug: OP0201	2	12
Total, other adverse events	Drug: Placebo	6	12
Total, serious adverse events	Drug: OP0201	0	12
Total, serious adverse events	Drug: Placebo	0	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 vs Drug: Placebo: Number of Participants With Adverse Events	Trial comparisons
Drug: OP0201 vs Drug: Placebo: deaths from any cause	Trial comparisons
Drug: OP0201 vs Drug: Placebo: 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/NCT03766373

GET https://conductscience.org/api/trials/v1/NCT03766373/registered

API reference For AI assistants