NCT03766373 is a Phase 1 clinical trial of Drug: OP0201 20mg in Acute Otitis Media, sponsored by Novus Therapeutics, Inc.

Who is sponsoring NCT03766373?

NCT03766373 is sponsored by Novus Therapeutics, Inc.

What drugs are being tested in NCT03766373?

Interventions in NCT03766373: Drug: OP0201 20mg, Drug: Placebo 0mg.

What condition does NCT03766373 study?

NCT03766373 studies Acute Otitis Media.

Is NCT03766373 still recruiting?

NCT03766373 is currently completed. Last updated 5 December 2019.

Are results published for NCT03766373?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-12-05 · How we verify

NCT03766373

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 5 December 2019

What this trial tests

Phase 1 trial testing Drug: OP0201 20mg in Acute Otitis Media in 24 participants. Completed in 30 January 2019.

Timeline

7 January 2019

Primary endpoint
30 January 2019

30 January 2019

Quick facts

Lead sponsor	Novus Therapeutics, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	24
Start date	7 January 2019
Primary completion	30 January 2019
Estimated completion	30 January 2019
Sites	2 locations across United States

Drugs / interventions tested

Drug: OP0201 20mg
Drug: Placebo 0mg

Conditions studied

Acute Otitis Media — all drugs for Acute Otitis Media →

Sponsor

Novus Therapeutics, Inc — full company profile →

Who can join

18 and older, any sex, with Acute Otitis Media. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · 1 Day

Group	Value	95% CI
Drug: OP0201	2
Drug: Placebo	6

Adverse events — posted to ClinicalTrials.gov

Time frame: 7 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Drug: OP0201

Serious: 0/12 (0%)

Deaths: 0/12

Drug: Placebo

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (8 terms — click to expand)

Reaction	System	Drug: OP0201	Drug: Placebo
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	—	—
Lacrimation increased	Eye disorders	—	—
Feeling cold	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT03766373 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Acute Otitis Media

Currently open trials in the same condition.

NCT07015736 — Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respir · Phase 4 · active not recruiting
NCT05915078 — Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry · recruiting

Other Novus Therapeutics, Inc trials

Trials by the same sponsor.

NCT03818815 — A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infa · Phase 2 · completed
NCT03828149 — Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults · Phase 1 · completed
NCT03748758 — Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03766373 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novus Therapeutics, Inc
Last refreshed: 5 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03766373.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing