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Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions

27 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

124

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Frankrike
      • Multiple Locations, Frankrike
        • Rekrytering
        • Multiples facilities
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain responder rate at Day 1
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain responder rate at Day 6 or end of study
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Laboratoires Elerte

Samarbetspartners

Clin-Experts

Utredare

  • Huvudutredare: Dominique DELSART

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 mars 2026

Primärt slutförande (Beräknad)

30 april 2027

Avslutad studie (Beräknad)

1 juli 2027

Studieregistreringsdatum

Först inskickad

27 maj 2026

Först inskickad som uppfyllde QC-kriterierna

27 maj 2026

Första postat (Faktisk)

2 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2025-A00279-40

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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