Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat

Sandoz229 enrolled

Overview

The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal S, topical spray \[Menthol\], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 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

229

Conditions

Sore Throat

Interventions

Angal S, topical spray [Menthol]DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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); * Body temperature 37,5 C (axillary). 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).

Locations (14)

Sandoz Investigational Site

Arkhangelsk, Russia

Sandoz Investigational Site

Moscow, Russia

Sandoz Investigational Site

Moscow, Russia

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

Outcomes

Primary Outcomes

Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)

The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15.

Time frame: 4 Days

Secondary Outcomes

Percentage of Participants With a ≥50% TSS Total Score Reduction

Percentage of participants with a ≥50% TSS Total Score Reduction according to the TSS questionnaire completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15.

Time frame: 4 days

Change From Baseline in TSS Total Score

Change from baseline in TSS total score completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15.

Time frame: 4 days

Number of Participants Who Fully Recovered

Number of Participants who Fully Recovered by Day 4 in Group A and by Day 5 in Group B (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2)

Time frame: Group A: 4 days Group B: 5 days

Change in the Sore Throat Intensity by 100 mm VAS

Change in the sore throat intensity by 100 mm VAS (visual analogue scale filled in by the patient) at the start and after 3 days of therapy. 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: 4 days

Period of Time Required for Disappearance of the Disease Symptoms

A period of time required for disappearance of the disease symptoms, determined according to the patient's diary (subjective patient's evaluation), but no more than 5 days during the trial-for patients who have achieved the corresponding outcome.

Time frame: 5 Days