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

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.

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 Overview

• Status: Completed
• Conditions: Sore Throat
• Intervention / Treatment: Drug: Angal, lozenges [menthol],; Drug: ANTI-ANGIN® FORMULA

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangel'sk, Russian Federation, 163000
    • Sandoz Investigational Site
  • Moscow, Russian Federation, 105018
    • Sandoz Investigational Site
  • Moscow, Russian Federation, 115280
    • Sandoz Investigational Site
  • Moscow, Russian Federation, 119192
    • Sandoz Investigational Site
  • Moscow, Russian Federation, 127015
    • Sandoz Investigational Site
  • Moscow, Russian Federation, 135215
    • Sandoz Investigational Site
  • Saint Petersburg, Russian Federation, 188643
    • Sandoz Investigational Site
  • Saint Petersburg, Russian Federation, 191036
    • Sandoz Investigational Site
  • Saint Petersburg, Russian Federation, 196143
    • Sandoz Investigational Site
  • Saint Petersburg, Russian Federation, 197706
    • Sandoz Investigational Site
  • Saint Petersburg, Russian Federation, 198207
    • Sandoz Investigational Site
  • Saint Petersburg, Russian Federation, 199178
    • Sandoz Investigational Site
  • Saint Petersburg, Russian Federation, 199226
    • Sandoz Investigational Site
  • Stavropol', Russian Federation, 355000
    • Sandoz Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; 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],; 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.
Active Comparator: Arm B; 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; 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.

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

Collaborators and Investigators

• Sponsor: Sandoz

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): May 7, 2017
• Study Completion (Actual): May 7, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: sore throat; no less therapeutic efficacy; Angal; ANTI-ANGIN® FORMULA
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: TE_004_ANG_LOZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No