Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions
2026년 5월 27일 업데이트: Laboratoires Elerte
Relief of Sore Throat Pain or Minor Mouth Lesions, Including Minor Aphthous Ulcers, in Children and Adults Treated With OROSEDAL: An Observational Study
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.
연구 개요
상세 설명
OROSEDAL is a CE-marked medical device intended to relieve sore throat, aphthous ulcers, oral lichen planus, and minor mouth lesions through a mechanical barrier and hydrating effect.
The study is conducted in French general practice under real-life conditions of use.
The decision to prescribe OROSEDAL is made independently from study participation.
Eligible patients aged 8 years or older with sore throat or minor oral lesions evolving for less than 15 days and baseline global pain intensity >40 mm on a 0-100 mm visual analog scale will be enrolled.
Data will be collected at inclusion, through a daily self-assessment diary, and at Day 6 ± 1 day or early termination.
The primary endpoint is the proportion of patients with a reduction >20 mm in global pain intensity over the previous 24 hours between Day 0 and Day 1 evening.
Secondary endpoints assess pain response at Day 6, immediate pain relief after first use, daily pain evolution, swallowing discomfort, global patient-rated effectiveness, associated symptoms, safety/tolerability, device deficiencies, and compliance.
연구 유형
관찰
등록 (추정된)
124
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Renaud URBINELLI
- 전화번호: +33756882093
- 이메일: etudes@clin-experts.fr
연구 장소
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Multiple Locations, 프랑스
- 모병
- Multiples facilities
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연락하다:
- Renaud URBINELLI
- 전화번호: +33756882093
- 이메일: etudes@clin-experts.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
Inclusion Criteria:
- 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.
- Written informed consent from the patient or from one parent for minors.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Patients treated with OROSEDAL
Children and adults aged 8 years or older consulting a general practitioner for sore throat or a minor oral lesion, for whom OROSEDAL has been prescribed in routine care before study inclusion.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain responder rate at Day 1
기간: Day 1 evening
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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.
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Day 1 evening
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain responder rate at Day 6 or end of study
기간: Day 6 ± 1 day or early termination.
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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.
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Day 6 ± 1 day or early termination.
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Immediate change in instantaneous pain intensity after first application
기간: Day 0: before first application, then 5 minutes, 10 minutes, and 60 minutes after first application.
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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.
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Day 0: before first application, then 5 minutes, 10 minutes, and 60 minutes after first application.
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Change in global pain intensity over the study period
기간: Day 0 to Day 6 ± 1 day or early termination.
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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.
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Day 0 to Day 6 ± 1 day or early termination.
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Change in swallowing discomfort
기간: Day 0 to Day 6 ± 1 day or early termination.
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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.
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Day 0 to Day 6 ± 1 day or early termination.
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Patient global assessment of effectiveness
기간: Day 6 ± 1 day or early termination.
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Patient-rated global effectiveness assessed using a 5-point numerical scale: 0 = not effective at all; 1 = very slightly effective; 2 = slightly effective; 3 = fairly effective; 4 = very effective.
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Day 6 ± 1 day or early termination.
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Evolution of associated clinical signs
기간: Day 0 to Day 6 ± 1 day or early termination
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Change in associated signs reported or observed during the study, including fever, headache, and other associated symptoms.
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Day 0 to Day 6 ± 1 day or early termination
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Adverse events, serious adverse events, incidents, and device deficiencies
기간: From inclusion to Day 6 ± 1 day or early termination.
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Number and description of adverse events, serious adverse events, incidents, and device deficiencies reported by the patient in the diary or collected by the investigator at visits.
Device deficiencies include any malfunction or inadequacy of the medical device when applicable.
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From inclusion to Day 6 ± 1 day or early termination.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 3월 5일
기본 완료 (추정된)
2027년 4월 30일
연구 완료 (추정된)
2027년 7월 1일
연구 등록 날짜
최초 제출
2026년 5월 27일
QC 기준을 충족하는 최초 제출
2026년 5월 27일
처음 게시됨 (실제)
2026년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 27일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-A00279-40
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