The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal, lozenges \[Menthol\], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, lozenges, 0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
228
Angal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution.
0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution.
Sandoz Investigational Site
Arkhangelsk, Russia
Sandoz Investigational Site
Moscow, Russia
Sandoz Investigational Site
Moscow, Russia
Percentage of Participants Without Sore Throat According to TSS Score
TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : \<37.5 °С; 1. pts : 37.5 to \<38.5 °С; 2. pts : 38.5 to \<39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.
Time frame: 4 days
50% Reduction Tss SCORE
Frequency of 50 % or more total score reduction by the TSS questionnaire completed by the Investigator relative to baseline in both Angal and ANTI-ANGIN FORMULA arms at visit 2
Time frame: day 4
Change From Baseline in TSS Total Score
Change from baseline in TSS total score. A negative change from baseline means an improvement.TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : \<37.5 °С; 1. pts : 37.5 to \<38.5 °С; 2. pts : 38.5 to \<39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.
Time frame: baseline and day 4
Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)
only patients for which outcomes were available were included , 111 out of 113 for Angal and 102 out of 107 for Antiangin, per protocol set
Time frame: 5 days
Number of Participants Who Fully Recovered up to Day 5
Number of participants who fully recovered up to day 5 (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sandoz Investigational Site
Moscow, Russia
Sandoz Investigational Site
Moscow, Russia
Sandoz Investigational Site
Moscow, Russia
Sandoz Investigational Site
Saint Petersburg, Russia
Sandoz Investigational Site
Saint Petersburg, Russia
Sandoz Investigational Site
Saint Petersburg, Russia
Sandoz Investigational Site
Saint Petersburg, Russia
...and 4 more locations
Time frame: 4 days for Angal, 5 days for AntiAngin
Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) .
The VAS is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The VAS ranges from 0 to 100. A decrease from baseline in the VAS score to reflect pain intensity indicates a decrease in pain intensity.
Time frame: baseline, day 4