Oxymetazoline Nasal Gel for Stuffy Nose
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 65 who currently have a stuffy nose from a cold or allergies. Participants must be generally healthy, meet certain symptom levels, and avoid nicotine and alcohol before the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer oxymetazoline HCl 0.05% nasal gel or placebo, once in each nostril
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oxymetazoline HCl 0.05% nasal gel
Trial Overview
The study compares oxymetazoline HCl 0.05% nasal gel with a placebo gel to see how well one dose relieves nasal congestion in the first two hours after use. It also checks safety and comfort of the gel.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Participants will self-administer placebo nasal gel, once in each nostril.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
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