A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults
2026年6月5日 更新者：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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
120
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
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Mississauga、Ontario、加拿大、L4W
- Cliantha Research
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Oxymetazoline HCl 0.05% nasal gel low dose
Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
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Single dose; intranasally, once in each nostril.
|
|
实验性的：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.
|
|
实验性的：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.
|
|
安慰剂比较：Placebo nasal gel
Participants will self-administer placebo nasal gel, once in each nostril.
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Single dose; intranasally, once in each nostril.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change from baseline (CFB) in nasal congestion considered by timepoint and difference over 2 hours post-treatment
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Onset of action: Timed frequency using VAS
大体时间：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
大体时间：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.
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From baseline to 2 hours post-administration
|
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Number of participants with adverse events (AEs), serious adverse events (SAEs), and Treatment Emergent AEs (TEAEs)
大体时间：From baseline to 2 hours post-administration
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From baseline to 2 hours post-administration
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|
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Participant satisfaction/tolerability of study interventions
大体时间：At 2 hours post-administration
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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).
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At 2 hours post-administration
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月20日
初级完成 (实际的)
2026年5月28日
研究完成 (实际的)
2026年5月28日
研究注册日期
首次提交
2026年5月6日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年6月8日
上次提交的符合 QC 标准的更新
2026年6月5日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
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