Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions
27 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
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 estudo
Observacional
Inscrição (Estimado)
124
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Renaud URBINELLI
- Número de telefone: +33756882093
- E-mail: etudes@clin-experts.fr
Locais de estudo
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Multiple Locations, França
- Recrutamento
- Multiples facilities
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Contato:
- Renaud URBINELLI
- Número de telefone: +33756882093
- E-mail: etudes@clin-experts.fr
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain responder rate at Day 1
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain responder rate at Day 6 or end of study
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dominique DELSART
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
5 de março de 2026
Conclusão Primária (Estimado)
30 de abril de 2027
Conclusão do estudo (Estimado)
1 de julho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
27 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de maio de 2026
Primeira postagem (Real)
2 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças bucais
- Doenças estomatognáticas
- Infecções do Trato Respiratório
- Infecções
- Doenças Respiratórias
- Erupções Liquenóides
- Doenças de Pele Papuloescamosas
- Doenças de pele
- Doenças Otorrinolaringológicas
- Doenças Faríngeas
- Estomatite
- Doenças da Pele e do Tecido Conjuntivo
- Líquen plano
- Líquen plano oral
- Faringite
- Úlcera oral
- Estomatite Aftosa
Outros números de identificação do estudo
- 2025-A00279-40
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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