A Phase 2 interventional study of Oxymetazoline HCl 0.05% nasal gel and Placebo nasal gel in Nasal Congestion, Nasal Obstruction, sponsored by Bayer. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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.
108 studies on the registry are indexed under Nasal Obstruction; 27 are open to participants now.
This study's enrollment of 120 is above the median of 52 across 80 interventional studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Drug: Oxymetazoline HCl 0.05% nasal gel
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Drug: Oxymetazoline HCl 0.05% nasal gel
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Drug: Oxymetazoline HCl 0.05% nasal gel
Participants will self-administer placebo nasal gel, once in each nostril.
Drug: Placebo nasal gel
Single dose; intranasally, once in each nostril.
Single dose; intranasally, once in each nostril.
The change from baseline (CFB) in nasal congestion considered by timepoint and difference over 2 hours post-treatment
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.
Time frame: From baseline to 2 hours post-administration
Onset of action: Timed frequency using VAS
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.
Time frame: 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
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.
Time frame: From baseline to 2 hours post-administration
Number of participants with adverse events (AEs), serious adverse events (SAEs), and Treatment Emergent AEs (TEAEs)
Time frame: From baseline to 2 hours post-administration
Participant satisfaction/tolerability of study interventions
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).
Time frame: At 2 hours post-administration
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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