Clinical Trial

A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults

Completed Phase 2
View on ClinicalTrials.gov →
Summary
Nasal congestion (a "stuffy nose") is a common symptom of colds and seasonal or year-round allergies. It happens when the tiny blood vessels and tissues inside the nose swell and leak fluid, producing more mucus. That swelling and extra fluid make the nasal passages narrower, which can make it hard to breathe through the nose, sleep, or do daily activities. Oxymetazoline works on alpha-adrenergic receptors in the tiny blood vessels inside the nose. When these receptors are activated, the blood vessels tighten (constrict), which helps reduce swelling and open the nasal passages. The study drug, oxymetazoline hydrochloride (HCl) 0.05% nasal gel, is a gel form of a well-known decongestant that is typically available as a nasal spray. The gel may remain in contact with the nose longer than a spray and could feel different to use. The main purpose of this study is to learn how well a single dose of oxymetazoline HCl 0.05% nasal gel relieves nasal congestion within the first 2 hours after dosing using two different measures. The study will also look at safety and how well people tolerate the gel.
Protocol Amendment History 3 changes
critical Trial completed 2026-06-09
notable Primary completion moved earlier: 2026-08-07 -> 2026-05-28 2026-06-09
minor Completion moved earlier: 2026-08-07 -> 2026-05-28 2026-06-09
Trial Details
NCT Number NCT07582328
Lead Sponsor Bayer
Conditions Nasal Congestion, Nasal Obstruction
Enrollment 120 participants
Start Date 2026-04-20
Primary Completion 2026-05-28 (estimated)
Study Completion 2026-05-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-08