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Oxymetazoline Nasal Gel for Stuffy Nose

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new nasal gel version of oxymetazoline, a popular decongestant, to evaluate its effectiveness in relieving stuffy noses caused by colds or allergies. Oxymetazoline opens nasal passages by tightening blood vessels in the nose. The study will compare different doses of the gel to a placebo (a substance with no active medicine) to assess its effectiveness within two hours of use. People who frequently experience nasal congestion from colds or allergies and do not smoke or drink alcohol regularly might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important medical advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you should avoid nicotine products, nicotine replacement therapy, and alcohol for at least 12 hours before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that oxymetazoline, a common nasal decongestant, is usually safe when used as directed. It works by tightening blood vessels in the nose, reducing swelling and stuffiness. This action can clear a blocked nose caused by allergies or colds.

However, using oxymetazoline for too long or more than recommended can cause side effects like increased congestion or a burning sensation in the nose. It is best to use it for short periods, no more than three days in a row, to avoid these issues. Overall, when used correctly, oxymetazoline provides safe temporary relief for a stuffy nose.12345

Why are researchers excited about this trial's treatments?

Most treatments for a stuffy nose, like oral decongestants and nasal sprays, help by shrinking swollen blood vessels in the nasal passages. However, oxymetazoline nasal gel is unique because it uses a gel form of oxymetazoline HCl, which can provide a longer-lasting effect by sticking to the nasal lining more effectively. This gel formulation could potentially mean less frequent application compared to traditional sprays. Researchers are excited because this method might offer more sustained relief with fewer doses, making it a convenient option for those struggling with nasal congestion.

What evidence suggests that oxymetazoline nasal gel could be an effective treatment for nasal congestion?

Research has shown that oxymetazoline, a nasal decongestant, effectively relieves stuffy noses. One study found that 72.2% of participants felt better within one minute, and 70.4% experienced relief lasting up to five hours. This treatment narrows blood vessels in the nose, reducing swelling and clearing nasal passages. The nasal gel form may adhere to nasal tissues longer than a spray, potentially increasing its effectiveness. Users have reported quick relief, making it a promising option for those with nasal congestion.14567

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

I have a stuffy nose from a recent cold or allergies and my symptoms are severe enough.
I have not used nicotine or alcohol for at least 12 hours before the study.
I am between 18 and 65 years old.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants self-administer oxymetazoline HCl 0.05% nasal gel or placebo, once in each nostril

Single dose
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 hours
1 visit (in-person)

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

Group I: Oxymetazoline HCl 0.05% nasal gel low doseExperimental Treatment1 Intervention
Group II: Oxymetazoline HCl 0.05% nasal gel intermediate doseExperimental Treatment1 Intervention
Group III: Oxymetazoline HCl 0.05% nasal gel high doseExperimental Treatment1 Intervention
Group IV: Placebo nasal gelPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

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 profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29785414/

Topical nasal decongestant oxymetazoline (0.05%) ...

This study shows for the first time, that oxymetazoline provides both statistically significant and clinically meaningful relief of nasal congestion and ...

2.

clinicaltrials.bayer.com

clinicaltrials.bayer.com/study/23157

Nasal congestion || Nasal Obstruction | Study 23157

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 ...

A Study to Learn More About How Well Oxymetazoline HCl ...

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 ...

Rise and fall of decongestants in treating nasal congestion ...

They found that 72.2% of patients benefited from 0.05% oxymetazoline hydrochloride nasal spray within 1 min, and the efficacy was maintained for 5 h in 70.4% of ...

Oxymetazoline (nasal route) - Side effects & dosage

Oxymetazoline is used for the temporary relief of nasal (of the nose) congestion or stuffiness caused by hay fever or other allergies, colds, or sinus trouble.

Systemic side effects of locally used oxymetazoline - PMC - NIH

Conclusion: Due to the damage that the long-term use of nasal spray including oxymetazoline, it may cause injury on the end organ, which we revealed in our ...

A Study to Learn More About How Well Oxymetazoline HCl ...

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 ...