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NCT Number: NCT03095521

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

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.

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Key information

Conditions

Sore Throat Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sandoz Investigational Site, Arkhangelsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Angal, lozenges [menthol],

Drug

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.

ANTI-ANGIN® FORMULA

Drug

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.

Primary outcomes

  1. Percentage of Participants Without Sore Throat According to TSS Score

    Time frame: 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

    • : 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.

Secondary outcomes

  1. 50% Reduction Tss SCORE

    Time frame: 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

  2. Change From Baseline in TSS Total Score

    Time frame: 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

    • : 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.

  3. Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)

    Time frame: 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

  4. Number of Participants Who Fully Recovered up to Day 5

    Time frame: 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)

  5. Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) .

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2017
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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