Health TrialsbyHealthPanel

Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions

ConditionsSore ThroatAphthous UlcerOral Lichen PlanusMinor Mouth LesionOral Pain
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

This trial does not accept healthy volunteers

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 population

Children and adults aged 8 years or older consulting French general practitioners for sore throat or minor oral lesions, including minor aphthous ulcers or histologically confirmed oral lichen planus, for whom OROSEDAL has been prescribed in routine care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • OROSEDAL

    Device

    OROSEDAL is an oral spray medical device used according to its instructions for use or according to the physician's prescription. It acts mechanically through barrier-forming and hydrating effects intended to soothe irritation and relieve pain in sore throat, aphthous ulcers, oral lichen planus, and minor mouth lesions.

Treatment groups

124 Participants
are divided into 1 treatment group
Group A: Patients treated with OROSEDAL1 intervention

Trial outcomes

Primary outcomes

1

Pain responder rate at Day 1

Percentage of patients with a reduction \>20 mm in global pain intensity over the previous 24 hours, measured on a 0-100 mm visual analog scale, between baseline Day 0 and the evening assessment at Day 1. The question asks the patient to rate the global pain over the previous 24 hours related to the sore throat or mouth lesion, with 0 corresponding to no pain and 100 to worst imaginable pain.

Time frame
Day 1 evening

Secondary outcomes

1

Pain responder rate at Day 6 or end of study

Percentage of patients with a reduction \>20 mm in global pain intensity over the previous 24 hours, measured on a 0-100 mm visual analog scale, between Day 0 and Day 6 ± 1 day or early termination.

Time frame
Day 6 ± 1 day or early termination.
2

Immediate change in instantaneous pain intensity after first application

Change in instantaneous pain intensity related to the sore throat or mouth lesion, measured on a 0-100 mm visual analog scale. The patient rates current pain "at the present moment," with 0 corresponding to no pain and 100 to worst imaginable pain.

Time frame
Day 0: before first application, then 5 minutes, 10 minutes, and 60 minutes after first application.
3

Change in global pain intensity over the study period

Evolution of global pain intensity over the previous 24 hours, measured repeatedly on a 0-100 mm visual analog scale at inclusion, in the daily self-assessment diary from Day 1 to the day before Day 6, and at Day 6 ± 1 day or early termination.

Time frame
Day 0 to Day 6 ± 1 day or early termination.
4

Change in swallowing discomfort

Evolution of swallowing discomfort measured on a 5-point numerical scale from 0 to 4: 0 = no discomfort; 1 = mild discomfort; 2 = moderate discomfort; 3 = severe discomfort; 4 = very severe discomfort.

Time frame
Day 0 to Day 6 ± 1 day or early termination.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Multiples facilitiesRecruiting Multiple LocationsFranceFrance

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laboratoires Elerte

Lead sponsor

Clin-Experts

Collaborator

Source ClinicalTrials.gov
Apply now