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Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions

27 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

124

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Francia
      • Multiple Locations, Francia
        • Reclutamento
        • Multiples facilities
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain responder rate at Day 1
Lasso di tempo: Day 1 evening
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.
Day 1 evening

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain responder rate at Day 6 or end of study
Lasso di tempo: Day 6 ± 1 day or early termination.
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.
Day 6 ± 1 day or early termination.
Immediate change in instantaneous pain intensity after first application
Lasso di tempo: Day 0: before first application, then 5 minutes, 10 minutes, and 60 minutes after first application.
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.
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
Lasso di tempo: Day 0 to Day 6 ± 1 day or early termination.
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.
Day 0 to Day 6 ± 1 day or early termination.
Change in swallowing discomfort
Lasso di tempo: Day 0 to Day 6 ± 1 day or early termination.
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.
Day 0 to Day 6 ± 1 day or early termination.
Patient global assessment of effectiveness
Lasso di tempo: Day 6 ± 1 day or early termination.
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.
Day 6 ± 1 day or early termination.
Evolution of associated clinical signs
Lasso di tempo: Day 0 to Day 6 ± 1 day or early termination
Change in associated signs reported or observed during the study, including fever, headache, and other associated symptoms.
Day 0 to Day 6 ± 1 day or early termination
Adverse events, serious adverse events, incidents, and device deficiencies
Lasso di tempo: From inclusion to Day 6 ± 1 day or early termination.
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.
From inclusion to Day 6 ± 1 day or early termination.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Laboratoires Elerte

Collaboratori

Clin-Experts

Investigatori

  • Investigatore principale: Dominique DELSART

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 marzo 2026

Completamento primario (Stimato)

30 aprile 2027

Completamento dello studio (Stimato)

1 luglio 2027

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025-A00279-40

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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