[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"minor-mouth-lesion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:minor-mouth-lesion":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100639225","observational-study-of-orosedal-in-sore-throat-and-minor-oral-lesions-100639225",false,"NCT07620353","Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions","Relief of Sore Throat Pain or Minor Mouth Lesions, Including Minor Aphthous Ulcers, in Children and Adults Treated With OROSEDAL: An Observational Study","Inclusion Criteria:\n\n* Age 8 years or older, including adults.\n* Sore throat or minor mouth lesion, including minor aphthous ulcer or histologically confirmed oral lichen planus, evolving for less than 15 days.\n* Global pain intensity over the previous 24 hours, spontaneous and\u002For during chewing or swallowing, \\>40 mm on a 0-100 mm visual analog scale.\n* OROSEDAL prescription decided by the investigator before inclusion.\n* Written informed consent from the patient or from one parent for minors.\n\nExclusion Criteria:\n\n* More than 3 visible oral mucosal lesions.\n* Post-intubation sore throat.\n* Corticosteroid use ongoing or within 3 days before inclusion.\n* NSAID use ongoing or within 3 days before inclusion.\n* Local treatment on the lesion ongoing or within 3 days before inclusion.\n* 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.\n* Weak or strong opioid analgesics ongoing or within 3 days before inclusion.\n* Signs suggesting a condition requiring additional investigations according to the investigator, except rapid streptococcal throat testing.\n* Signs suggesting a condition requiring corticosteroid prescription according to the investigator.\n* Systemic disease, such as rheumatoid arthritis, lupus, or Behçet disease.\n* Any contraindication listed in OROSEDAL instructions for use.\n* Known allergy to any OROSEDAL component, including glycerol, tamarind extract, mallow extract, benzyl alcohol, orange blossom flavoring, or xylitol.\n* Non-compliance with precautions for use listed in the instructions for use.","ALL","8 Years",{"count":19,"type":20},124,"ESTIMATED","OBSERVATIONAL","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.",[24,25,26,27,28],"Sore Throat","Aphthous Ulcer","Oral Lichen Planus","Minor Mouth Lesion","Oral Pain",[30,31,32,33,34,35,36],"sore throat","aphthous ulcer","mouth ulcer","oral lesion","PMCF","real-world evidence","swallowing discomfort","RECRUITING","2026-05-27",{"date":40,"type":41},"2026-06-02","ACTUAL",{"date":43,"type":41},"2026-03-05",{"date":45,"type":20},"2027-07",{"name":47,"class":48},"Laboratoires Elerte","INDUSTRY"]