Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions
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
| Condition(s) | Sore Throat, Aphthous Ulcer, Oral Lichen Planus, Minor Mouth Lesion, Oral Pain |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 8 Years |
| Sex | All |
| Lead sponsor | Laboratoires Elerte |
| Locations | Multiple Locations, France |
| Start date | 2026-03-05 |
| NCT ID | NCT07620353 |
| Official listing | https://clinicaltrials.gov/study/NCT07620353 |