Observational Study of OROSEDAL for Sore Throat and Minor Mouth Lesions in Children and Adults

What this Trial Is About

Researchers are conducting an observational study to assess the performance and safety of OROSEDAL, an oral spray medical device, in children and adults with sore throat or minor oral lesions such as minor aphthous ulcers and oral lichen planus. This study takes place in real-life general practice settings and includes patients aged 8 years and older who have had symptoms for less than 15 days and significant pain levels. The goal is to gather real-world information on how OROSEDAL is used and its effects on pain and discomfort. Participants are those who have been prescribed OROSEDAL independently of the study. They will use the product as directed, and data will be collected at the start, daily through self-assessment diaries, and at Day 6 7 days or upon early study exit. The study focuses on pain relief, swallowing discomfort, treatment use, safety, device performance, and patient compliance in typical care settings. During the study, participants will record their pain, swallowing discomfort, symptoms, and any adverse events daily. Researchers will evaluate pain reduction at Day 1 evening as the primary outcome and assess additional measures such as pain at Day 6, immediate pain relief after use, and overall patient-rated effectiveness. Safety and any device issues will be monitored from inclusion through Day 6. The study duration per participant is approximately 6 days.

Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions