NCT07620353 Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions
| NCT ID | NCT07620353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laboratoires Elerte |
| Condition | Sore Throat |
| Study Type | OBSERVATIONAL |
| Enrollment | 124 participants |
| Start Date | 2026-03-05 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 124 participants in total. It began in 2026-03-05 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Dominique DELSART
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT07620353 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Sore Throat. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07620353 currently recruiting?
Yes, NCT07620353 is actively recruiting participants. Contact the research team at etudes@clin-experts.fr for enrollment information.
Where is the NCT07620353 trial being conducted?
This trial is being conducted at Multiple Locations, France.
Who is sponsoring the NCT07620353 clinical trial?
NCT07620353 is sponsored by Laboratoires Elerte. The principal investigator is Dominique DELSART. The trial plans to enroll 124 participants.