Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions

Официальное название

Relief of Sore Throat Pain or Minor Mouth Lesions, Including Minor Aphthous Ulcers, in Children and Adults Treated With OROSEDAL: An Observational Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство OROSEDAL
  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.

Первичные конечные точки

• Pain responder rate at Day 1 [Срок оценки: Day 1 evening]

Вторичные конечные точки (7)

• Pain responder rate at Day 6 or end of study [Срок оценки: Day 6 ± 1 day or early termination.]
• Immediate change in instantaneous pain intensity after first application [Срок оценки: Day 0: before first application, then 5 minutes, 10 minutes, and 60 minutes after first application.]
• Change in global pain intensity over the study period [Срок оценки: Day 0 to Day 6 ± 1 day or early termination.]
• Change in swallowing discomfort [Срок оценки: Day 0 to Day 6 ± 1 day or early termination.]
• Patient global assessment of effectiveness [Срок оценки: Day 6 ± 1 day or early termination.]
• Evolution of associated clinical signs [Срок оценки: Day 0 to Day 6 ± 1 day or early termination]
• Adverse events, serious adverse events, incidents, and device deficiencies [Срок оценки: From inclusion to Day 6 ± 1 day or early termination.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Multiples facilities — Multiple Locations

Идентификаторы

NCT: NCT07620353 · 2025-A00279-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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