OROSEDAL use in sore throat and minor oral lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study assesses the performance and safety of OROSEDAL when used in routine care for patients with sore throat or minor oral lesions, including minor aphthous ulcers and histologically confirmed oral lichen planus. Participants are enrolled after a clinician prescribes OROSEDAL and followed for about six days, with daily self-reports of pain, swallowing discomfort, use of the product, and any adverse events. The primary endpoint evaluates whether global pain intensity decreases by more than 20 mm on a 0–100 mm scale from day 0 to day 1 evening. Secondary endpoints include pain relief at day 6, immediate relief after first use, daily pain trajectory, swallowing symptoms, patient-rated effectiveness, safety, device issues, and compliance. Data collection occurs at enrollment, daily diary entries, and a final assessment around day 6 or early termination.

Why it matters

Who can join: the full rules

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.

Where it's running

• Multiples facilities
  Multiple Locations, France Recruiting

Study contacts

• Principal investigator: Dominique DELSART
• Study coordinator: Renaud Urbinelli
• Email: etudes@clin-experts.fr
• Phone: +33756882093

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.