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

Study Overview
=================
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.

Official Title
-----------------
A Prospective, Multi-center, Open, Randomized Clinical Study in Parallel Groups, for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol], 1 mg + 5 mg (Sandoz d.d., Slovenia), and 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.

Conditions
-----------------
Sore Throat

Intervention / Treatment
-----------------
* Drug: Angal, lozenges [menthol],
* Drug: ANTI-ANGIN® FORMULA


Participation Criteria
=================
Eligibility Criteria
-----------------
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);

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>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. | Drug: Angal, lozenges [menthol],<br>* 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.<br>|
| Active Comparator: Arm B<br>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. | Drug: ANTI-ANGIN® FORMULA<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 : insignificant symptom : moderate symptom : significant symptom fever 0 pts : <37.5 °С; pts : 37.5 to <38.5 °С; pts : 38.5 to <39.5 °С; pts : ≥ 39.5 °С. TSS total ranges are 0-15. | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 : insignificant symptom : moderate symptom : significant symptom fever 0 pts : <37.5 °С; pts : 37.5 to <38.5 °С; pts : 38.5 to <39.5 °С; pts : ≥ 39.5 °С. TSS total ranges are 0-15. | 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 | 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) | 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. | baseline, day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angal, ANTI-ANGIN® FORMULA, sore throat, no less therapeutic efficacy