Actively Recruiting
A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults
Led by Bayer · Updated on 2026-05-12
120
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants, age between 18 to 65 years at the time of signing the informed consent.
- Participants in good general health per medical evaluation (medical, allergy, and social history; physical and nasal examinations).
- Participants who self-report acute nasal congestion as symptoms of an acute upper respiratory tract infection or allergies and a VAS score meeting the study-defined threshold.
- Participants should abstain from use of nicotine products or any forms of nicotine replacement therapy, and consuming alcohol at least 12 hours prior to the study.
You will not qualify if you...
- Severe, unstable, or uncontrolled cardiovascular disease, cerebral or coronary insufficiency, Raynaud's Syndrome, thromboangitis obliterans, scleroderma, Sjögren's syndrome, renal or hepatic impairment, thyroid disease, diabetes, chronic congestion, COVID, influenza, or enlarged prostate.
- Narrow angle glaucoma.
- History of nasal surgery or nasal abnormalities.
- History of frequent nosebleeds or rhinitis medicamentosa.
- Females who are pregnant, breastfeeding, or planning a pregnancy.
- Inflammation of the skin and mucosa of nasal vestibule and encrustation (rhinitis sicca).
- Acute or chronic illnesses affecting sensory function.
- History of drug or alcohol abuse within 12 months prior to the study visit.
- Positive drug, alcohol, or carbon monoxide test.
- History of sensitivity or anaphylaxis to any of the study medications.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cliantha Research
Mississauga, Ontario, Canada, L4W
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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