Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8+
SponsorLaboratoires Elerte
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- OROSEDAL
Treatment groups
124 Participants
are divided into 1 treatment groupLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Multiples facilitiesRecruiting Multiple Locations
France
FranceSponsors and collaborators
Laboratoires Elerte
Lead sponsor
Clin-Experts
Collaborator
Source ClinicalTrials.gov