A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat

Phase 3

Completed

Conditions: Sore Throat

Interventions: Drug: Angal, lozenges [menthol],
Drug: ANTI-ANGIN® FORMULA

Registration Number: NCT03095521

Lead Sponsor: Sandoz

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 228

Inclusion Criteria

Voluntarily signed informed consent for participation in this clinical study; 18 to 45 years old inclusive, male and female;
Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat;
Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study;
Baseline TSS score (Tonsillopharyngitis Severity Score) ≥ 5 (total score);

Exclusion Criteria

Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during the study;
Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during the study;
Use of local therapy (sprays, rinses, lozenges) to pharynx within <12 hours before study start or/and inability to cancel them, besides study medications.
Use systemic or inhaled corticosteroids within ≤1 months prior to the study start and planned therapy of them during the study (besides skin means).
Presence of symptoms of primary bacterial pharyngitis or secondary bacterial infection (including fever over 37,5 ° C, the presence of purulent raids in the throat, severe intoxication, leukocytosis, neutrophilia, shift leukocyte left (increasing the percentage of neutrophils sticks appearance younger forms of neutrophils), increased ESR 30 mm/hr);

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Angal, lozenges [menthol],	Angal, lozenges, 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, if this will happen earlier than 4th day of treatment.
Arm B	ANTI-ANGIN® FORMULA	ANTIANGIN ® FORMULA, 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, if this will happen earlier than 5th day of treatment.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Without Sore Throat According to TSS Score	4 days	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.

Secondary Outcome Measures

Name	Time	Method
50% Reduction Tss SCORE	day 4	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
Change From Baseline in TSS Total Score	baseline and day 4	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.
Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)	5 days	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
Number of Participants Who Fully Recovered up to Day 5	4 days for Angal, 5 days for AntiAngin	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)
Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) .	baseline, day 4	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.