Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat

• Status: Completed
• Trial end date: 2018-05-24
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bosnalijek D.D
• Collaborator: MonitorCRO
• Treatments: Benzydamine; Lidocaine

Criteria

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 hypersensitiveness to egg white and other allergens

• Patients who are pregnant or breastfeeding