Status:
COMPLETED
Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat
Lead Sponsor:
Bosnalijek D.D
Collaborating Sponsors:
MonitorCRO
Conditions:
Sore Throat
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This study will be conducted in approximately 3 centers in Bosnia Herzegovina and in 4 centers in Turkey. Primary objective: The primary objective of this study is to evaluate superiority of Lysobac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2018
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT03282045
Start Date
October 1 2016
End Date
May 24 2018
Last Update
March 16 2021
Active Locations (1)
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1
University Clinical Center of the Republic of Srpska, ENT Clinic, Banja Luka, Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000