Actively Recruiting
Relief of Sore Throat Pain or Minor Mouth Lesions, Including Minor Aphthous Ulcers, in Children and Adults Treated With OROSEDAL: An Observational Study
Led by Laboratoires Elerte · Updated on 2026-06-02
124
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
L
Laboratoires Elerte
Lead Sponsor
C
Clin-Experts
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 greater than 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 15 days since symptom onset
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 6 days with an allowable 1-day window
Participants use OROSEDAL as prescribed in routine care and record daily self-assessments of pain and related symptoms.
1 baseline visit and 1 follow-up visit around Day 6
Trial Site Locations
Total: 1 location
1
Multiples facilities
Multiple Locations, France
Actively Recruiting
Research Team
R
Renaud Urbinelli
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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