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

NCT07582328 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Nasal Congestion
  • Nasal Obstruction

Interventions

DRUG

Oxymetazoline HCl 0.05% nasal gel

Single dose; intranasally, once in each nostril.

DRUG

Placebo nasal gel

Single dose; intranasally, once in each nostril.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2026-08-07
Completion
2026-08-07

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07582328 on ClinicalTrials.gov