Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions
27 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
124
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Renaud Urbinelli
- Número de teléfono: +33756882093
- Correo electrónico: etudes@clin-experts.fr
Ubicaciones de estudio
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Multiple Locations, Francia
- Reclutamiento
- Multiples facilities
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Contacto:
- Renaud Urbinelli
- Número de teléfono: +33756882093
- Correo electrónico: etudes@clin-experts.fr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain responder rate at Day 1
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain responder rate at Day 6 or end of study
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dominique DELSART
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de marzo de 2026
Finalización primaria (Estimado)
30 de abril de 2027
Finalización del estudio (Estimado)
1 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de mayo de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Infecciones del Tracto Respiratorio
- Infecciones
- Enfermedades de las vías respiratorias
- Erupciones liquenoides
- Enfermedades De La Piel Papuloescamosa
- Enfermedades de la piel
- Enfermedades Otorrinolaringológicas
- Enfermedades faríngeas
- Estomatitis
- Enfermedades de la piel y del tejido conectivo
- Liquen plano
- Liquen Plano Oral
- Faringitis
- Úlcera oral
- Estomatitis Aftosa
Otros números de identificación del estudio
- 2025-A00279-40
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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