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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Mississauga, Ontario, Canada, L4W
- Cliantha Research
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Oxymetazoline HCl 0.05% nasal gel low dose
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
|
Single dose; intranasally, once in each nostril.
|
|
Eksperimentell: Oxymetazoline HCl 0.05% nasal gel intermediate dose
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
|
Single dose; intranasally, once in each nostril.
|
|
Eksperimentell: Oxymetazoline HCl 0.05% nasal gel high dose
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
|
Single dose; intranasally, once in each nostril.
|
|
Placebo komparator: Placebo nasal gel
Participants will self-administer placebo nasal gel, once in each nostril.
|
Single dose; intranasally, once in each nostril.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. april 2026
Primær fullføring (Faktiske)
28. mai 2026
Studiet fullført (Faktiske)
28. mai 2026
Datoer for studieregistrering
Først innsendt
6. mai 2026
Først innsendt som oppfylte QC-kriteriene
6. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 23157
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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