Evaluation of Treatments for Sore Throat Associated With Acute Pharyngitis and/or Viral Tonsillitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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…),
Trial design
Design model
Parallel
Treatments tested in this trial
HMG
DevicePatients included in the "HMG" arm will receive the medical device of the same name.
PHN
DevicePatients included in the "PHN" arm will receive the medical device of the same name.
PHR
DevicePatients included in the "PHR" arm will receive the medical device of the same name.
TUR
DevicePatients included in the "TUR" arm will receive the medical device of the same name.
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: HMGExperimental treatment 1 intervention
Group B: PHNExperimental treatment 1 intervention
Group C: PHRExperimental treatment 1 intervention
Group D: TURExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tolerance
Collection of adverse events (AEs) during the period of use of HMG, PHN, PHR, TUR products in an electronic daily recording book
Time frame
From visit 1 (day 1) to visit 2 (day 8)Secondary outcomes
1
Efficiency
Clinical improvement (yes/no) defined as a decrease of at least 30% in the "total score for symptoms of sore throats" (STSMG) between baseline and the average of the scores measured during the last 3 days of use of the study product (days 5,6,7).
Time frame
From visit 1 (day 1) to the last day of use of the study product (day 8)2
Efficiency
Clinical improvement (yes/no) at the medical examination: the assessment of pharyngeal erythema and general signs (lymphadenopathy, fever) by comparing the patient's data at inclusion and during the visit on day 8.
Time frame
From visite 1 (day 1) to visit 2 (day 8)3
Quality of life impact
Change in quality of life measured by four questions before (Day 1) and after (Day 8) use of the study products concerning sleep, daily activities, fatigue, and irritability. Each response will be rated between 0 (not impacted) and 10 (highly impacted) on a visual analog scale.
Time frame
From visite 1 (day 1) to visit 2 (day 8)4
Device defect
Device defect assessed by recording any defect in terms of identity, quality, durability, reliability, safety, or performance, malfunction, or user error, or any defect in the information provided by the manufacturer in the electronic record book.
Time frame
From visit A (day 1) to visit 2 (day 8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov