Ireland
--:--IST
Recruiting Not applicable

Evaluation of Treatments for Sore Throat Associated With Acute Pharyngitis and/or Viral Tonsillitis

NCT07569939 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-07-29
Last updated
2026-08-05

Condition(s) studied

Acute PharyngitisViral Sore Throat

Investigational drug(s) / intervention(s)

HMGPHNPHRTUR

HMG: Patients included in the "HMG" arm will receive the medical device of the same name.

PHN: Patients included in the "PHN" arm will receive the medical device of the same name.

PHR: Patients included in the "PHR" arm will receive the medical device of the same name.

TUR: Patients included in the "TUR" arm will receive the medical device of the same name.

Study summary

The objective of this study is to conduct post-marketing clinical follow-up of four products: HMG, PHN, PHR, and TUR. This follow-up will consist of collecting clinical data in real-life conditions to confirm the tolerance, safety, and efficacy of medical devices used in the treatment of sore throats related to acute pharyngitis and/or viral-origin tonsillitis, while also assessing the benefit/risk ratio of the products.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Pharyngitis or tonsillitis or acute nasopharyngitis or viral-origin sore throat with odynophagia that began less than 72 hours before the inclusion visit according to the investigator's judgment * Bacterial rhinopharyngitis with negative TROD test * Effective contraception for female patients of childbearing age * Cooperation and sufficient understanding to comply with the requirements of the trial * Acceptance of registration in the SI-RIPH database * Having received informed information and agreeing to give written consent * Affiliated with the French Social Security scheme. Exclusion Criteria: * Hypersensitivity/previous allergy to any of the product components, * Pharyngitis or tonsillitis or acute rhinopharyngitis complicated (phlegmon, acute otitis media, pneumonia…) or severely intolerable cough, * Positive antigen test for influenza A/B or COVID-19 and infection requiring etiological treatment according to the recommendations, * Other ongoing treatments for acute pharyngitis or tonsillitis (local treatment, antibiotics, corticosteroids, antiretroviral…), * Comorbidities or health conditions deemed incompatible with the trial by the investigator, * Recent otorhinolaryngology surgery (\<6 months), * Pulmonary pathology (Chronic Obstructive Pulmonary Disease, asthma…), * Immunosuppression (according to patient's report), * Pregnant or breastfeeding women, * Currently participating in another clinical trial, or in the exclusion period, or having received total compensation of more than €6,000 in the 12 months prior to the start of the trial, * Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).

Primary outcome measure(s)

  • Tolerance — From visit 1 (day 1) to visit 2 (day 8)
    Collection of adverse events (AEs) during the period of use of HMG, PHN, PHR, TUR products in an electronic daily recording book

Trial sites (1)

FacilityCityRegionStatus
Chu Clermont Ferrand Clermont-Ferrand France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07569939 on ClinicalTrials.gov ↗ ← All trials in France