Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions
2026年5月27日 更新者：Laboratoires Elerte
Relief of Sore Throat Pain or Minor Mouth Lesions, Including Minor Aphthous Ulcers, in Children and Adults Treated With OROSEDAL: An Observational Study
This prospective, multicenter, national, observational, non-interventional post-market clinical follow-up study will evaluate the performance and safety of OROSEDAL in children and adults with sore throat or minor oral lesions, including minor aphthous ulcers and histologically confirmed oral lichen planus.
OROSEDAL is prescribed in routine practice before inclusion.
Patients will be followed for 6 ± 1 days and will complete self-assessments of pain, swallowing discomfort, treatment use, and adverse events.
研究概览
详细说明
OROSEDAL is a CE-marked medical device intended to relieve sore throat, aphthous ulcers, oral lichen planus, and minor mouth lesions through a mechanical barrier and hydrating effect.
The study is conducted in French general practice under real-life conditions of use.
The decision to prescribe OROSEDAL is made independently from study participation.
Eligible patients aged 8 years or older with sore throat or minor oral lesions evolving for less than 15 days and baseline global pain intensity >40 mm on a 0-100 mm visual analog scale will be enrolled.
Data will be collected at inclusion, through a daily self-assessment diary, and at Day 6 ± 1 day or early termination.
The primary endpoint is the proportion of patients with a reduction >20 mm in global pain intensity over the previous 24 hours between Day 0 and Day 1 evening.
Secondary endpoints assess pain response at Day 6, immediate pain relief after first use, daily pain evolution, swallowing discomfort, global patient-rated effectiveness, associated symptoms, safety/tolerability, device deficiencies, and compliance.
研究类型
观察性的
注册 (估计的)
124
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。
学习联系方式
- 姓名：Renaud URBINELLI
- 电话号码：+33756882093
- 邮箱：etudes@clin-experts.fr
学习地点
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Multiple Locations、法国
- 招聘中
- Multiples facilities
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接触：
- Renaud URBINELLI
- 电话号码：+33756882093
- 邮箱：etudes@clin-experts.fr
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-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Children and adults aged 8 years or older consulting French general practitioners for sore throat or minor oral lesions, including minor aphthous ulcers or histologically confirmed oral lichen planus, for whom OROSEDAL has been prescribed in routine care.
描述
Inclusion Criteria:
- Age 8 years or older, including adults.
- Sore throat or minor mouth lesion, including minor aphthous ulcer or histologically confirmed oral lichen planus, evolving for less than 15 days.
- Global pain intensity over the previous 24 hours, spontaneous and/or during chewing or swallowing, >40 mm on a 0-100 mm visual analog scale.
- OROSEDAL prescription decided by the investigator before inclusion.
- Written informed consent from the patient or from one parent for minors.
Exclusion Criteria:
- More than 3 visible oral mucosal lesions.
- Post-intubation sore throat.
- Corticosteroid use ongoing or within 3 days before inclusion.
- NSAID use ongoing or within 3 days before inclusion.
- Local treatment on the lesion ongoing or within 3 days before inclusion.
- Non-opioid analgesics, including paracetamol, ongoing or within 3 days before inclusion, unless continued for at least 24 hours at the same daily dose as during the 24 hours before inclusion.
- Weak or strong opioid analgesics ongoing or within 3 days before inclusion.
- Signs suggesting a condition requiring additional investigations according to the investigator, except rapid streptococcal throat testing.
- Signs suggesting a condition requiring corticosteroid prescription according to the investigator.
- Systemic disease, such as rheumatoid arthritis, lupus, or Behçet disease.
- Any contraindication listed in OROSEDAL instructions for use.
- Known allergy to any OROSEDAL component, including glycerol, tamarind extract, mallow extract, benzyl alcohol, orange blossom flavoring, or xylitol.
- Non-compliance with precautions for use listed in the instructions for use.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Patients treated with OROSEDAL
Children and adults aged 8 years or older consulting a general practitioner for sore throat or a minor oral lesion, for whom OROSEDAL has been prescribed in routine care before study inclusion.
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OROSEDAL is an oral spray medical device used according to its instructions for use or according to the physician's prescription.
It acts mechanically through barrier-forming and hydrating effects intended to soothe irritation and relieve pain in sore throat, aphthous ulcers, oral lichen planus, and minor mouth lesions.
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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 |
|---|---|---|
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Pain responder rate at Day 1
大体时间：Day 1 evening
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Percentage of patients with a reduction >20 mm in global pain intensity over the previous 24 hours, measured on a 0-100 mm visual analog scale, between baseline Day 0 and the evening assessment at Day 1.
The question asks the patient to rate the global pain over the previous 24 hours related to the sore throat or mouth lesion, with 0 corresponding to no pain and 100 to worst imaginable pain.
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Day 1 evening
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain responder rate at Day 6 or end of study
大体时间：Day 6 ± 1 day or early termination.
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Percentage of patients with a reduction >20 mm in global pain intensity over the previous 24 hours, measured on a 0-100 mm visual analog scale, between Day 0 and Day 6 ± 1 day or early termination.
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Day 6 ± 1 day or early termination.
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Immediate change in instantaneous pain intensity after first application
大体时间：Day 0: before first application, then 5 minutes, 10 minutes, and 60 minutes after first application.
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Change in instantaneous pain intensity related to the sore throat or mouth lesion, measured on a 0-100 mm visual analog scale.
The patient rates current pain "at the present moment," with 0 corresponding to no pain and 100 to worst imaginable pain.
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Day 0: before first application, then 5 minutes, 10 minutes, and 60 minutes after first application.
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Change in global pain intensity over the study period
大体时间：Day 0 to Day 6 ± 1 day or early termination.
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Evolution of global pain intensity over the previous 24 hours, measured repeatedly on a 0-100 mm visual analog scale at inclusion, in the daily self-assessment diary from Day 1 to the day before Day 6, and at Day 6 ± 1 day or early termination.
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Day 0 to Day 6 ± 1 day or early termination.
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Change in swallowing discomfort
大体时间：Day 0 to Day 6 ± 1 day or early termination.
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Evolution of swallowing discomfort measured on a 5-point numerical scale from 0 to 4: 0 = no discomfort; 1 = mild discomfort; 2 = moderate discomfort; 3 = severe discomfort; 4 = very severe discomfort.
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Day 0 to Day 6 ± 1 day or early termination.
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Patient global assessment of effectiveness
大体时间：Day 6 ± 1 day or early termination.
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Patient-rated global effectiveness assessed using a 5-point numerical scale: 0 = not effective at all; 1 = very slightly effective; 2 = slightly effective; 3 = fairly effective; 4 = very effective.
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Day 6 ± 1 day or early termination.
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Evolution of associated clinical signs
大体时间：Day 0 to Day 6 ± 1 day or early termination
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Change in associated signs reported or observed during the study, including fever, headache, and other associated symptoms.
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Day 0 to Day 6 ± 1 day or early termination
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Adverse events, serious adverse events, incidents, and device deficiencies
大体时间：From inclusion to Day 6 ± 1 day or early termination.
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Number and description of adverse events, serious adverse events, incidents, and device deficiencies reported by the patient in the diary or collected by the investigator at visits.
Device deficiencies include any malfunction or inadequacy of the medical device when applicable.
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From inclusion to Day 6 ± 1 day or early termination.
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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。
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3月5日
初级完成 (估计的)
2027年4月30日
研究完成 (估计的)
2027年7月1日
研究注册日期
首次提交
2026年5月27日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年5月1日
更多信息
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