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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

5. juni 2026 opdateret af: Bayer

A Placebo-Controlled, Double-Blind, Dose-Finding Study to Evaluate Efficacy and Safety of 0.05% Oxymetazoline HCl Nasal Gel in Healthy Adults, 18-65 Years of Age

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L4W
        • Cliantha Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any of the following conditions: severe or 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 and enlarged prostate.
  • Participants with narrow angle glaucoma.
  • History of nasal surgery or nasal abnormalities.
  • Participants with history of frequent nosebleeds or with rhinitis medicamentosa.
  • Females who are pregnant, breast feeding, or planning a pregnancy.
  • Participants with inflammation of the skin and mucosa of nasal vestibule and encrustation (rhinitis sicca).
  • Presence of acute or chronic illnesses that may affect sensory function.
  • A history of drug or alcohol abuse within 12 months prior to the study visit.
  • A positive drug /alcohol/CO test.
  • History of sensitivity/ anaphylaxis to any of the study medications.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Oxymetazoline HCl 0.05% nasal gel low dose
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Medicin: Oxymetazoline HCl 0.05% nasal gel
Single dose; intranasally, once in each nostril.
Eksperimentel: Oxymetazoline HCl 0.05% nasal gel intermediate dose
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Medicin: Oxymetazoline HCl 0.05% nasal gel
Single dose; intranasally, once in each nostril.
Eksperimentel: Oxymetazoline HCl 0.05% nasal gel high dose
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Medicin: Oxymetazoline HCl 0.05% nasal gel
Single dose; intranasally, once in each nostril.
Placebo komparator: Placebo nasal gel
Participants will self-administer placebo nasal gel, once in each nostril.
Medicin: Placebo nasal gel
Single dose; intranasally, once in each nostril.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change from baseline (CFB) in nasal congestion considered by timepoint and difference over 2 hours post-treatment
Tidsramme: From baseline to 2 hours post-administration
Subjective feeling of nasal congestion will be evaluated by the 100 mm Visual Analog Score (VAS) (0-100 mm): 0 being completely clear and 100 being completely obstructed.
From baseline to 2 hours post-administration

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Onset of action: Timed frequency using VAS
Tidsramme: From baseline to 2 hours post-administration

VAS (0-100 mm): 0 being completely clear and 100 being completely obstructed.

VAS scoring will be assessed at baseline and from 10 seconds post-study intervention administration to establish the earliest onset of action.
From baseline to 2 hours post-administration
The change from baseline in Peak Nasal Inspiratory Flow (PNIF) measurement via nasal peak flow by timepoint and averaged over 2 hours post-treatment
Tidsramme: From baseline to 2 hours post-administration
The participant's PNIF will be measured with a device coupled to the anterior region of the nose through a mask connected to a plastic cylinder through which the forced inspired air passes. Participants will be trained on the performance of PNIF prior to dosing. Each participant will undergo 3 maneuvers at each specified timepoint, and all 3 attempts will be documented. Only the highest value of the 3 maneuvers will be used for assessment of endpoint analysis.
From baseline to 2 hours post-administration
Number of participants with adverse events (AEs), serious adverse events (SAEs), and Treatment Emergent AEs (TEAEs)
Tidsramme: From baseline to 2 hours post-administration
From baseline to 2 hours post-administration
Participant satisfaction/tolerability of study interventions
Tidsramme: At 2 hours post-administration
Participant satisfaction/tolerability will be evaluated by means of a five-point verbal rating scale to responses to a questionnaire (0 = very good, 1 = good, 2 = satisfactory, 3 = minimal, 4 = none).
At 2 hours post-administration

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. april 2026

Primær færdiggørelse (Faktiske)

28. maj 2026

Studieafslutning (Faktiske)

28. maj 2026

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 23157

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Nasal Congestion, Nasal Obstruction

Kliniske forsøg med Oxymetazoline HCl 0.05% nasal gel

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