Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spra… (NCT03282045) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat
Bosnia and Herzegovina346 participantsStarted 2016-10
Plain-language summary
The primary objective of this multicenter, single-blind, randomized, placebo-controlled, prospective, comparative study with parallel design and 4-arms is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with acute tonsillo-pharyngitis symptoms in common cold and by using a scale-based symptom Tonsillo-Pharyngitis Assessment (TPA) as an objective finding of pharyngeal infection, with a score of ≥5
* Patients who will be treated only on a symptomatic treatment basis, and with a prescribed a oropharyngeal spray
* Patients, 18 years of age and above, who provided an informed consent
* Patients with a sore-throat of recent onset, symptoms initiated ≤48 hours
* Patients with sore throat pain rated ≥66 mm on the Sore Throat Pain Intensity Scale (STPIS)
* Patients with difficulty in swallowing rated ≥50 mm on Difficulty Swallowing Scale (DSS)
* Patients with a sensation of swollen throat rated ≥33 mm on the Swollen Throat Scale (SwoTS)
Exclusion Criteria:
* Patients who had any previous (within 4 hours prior to screening examination) throat lozenge treatment/use
* Patients who had used any flu-preparation which contains any analgesic ingredient such as paracetamol, ibuprofen or acetylsalicylic acid (ASA) along with a decongestant
* Patients who had analgesic use (any) 4 hours prior to the screening examination
* Patients who are prescribed an antibiotic use before the screening visit and are entitled to use antibiotics during the course of this non-interventional study
* Patients with a known hypersensitivity to active/inactive ingredients of medications which is prescribed for the symptomatic treatment of sore throat
* Patients with known hypersens…
What they're measuring
1
to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators