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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

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ClinicalTrials.gov Identifier: NCT03095521
Recruitment Status : Completed
First Posted : March 29, 2017
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sore Throat Drug: Angal, lozenges [menthol], Drug: ANTI-ANGIN® FORMULA Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : May 7, 2017
Actual Study Completion Date : May 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat
Drug Information available for: Menthol

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.




Primary Outcome Measures :
  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

    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 :
  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

    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.

  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095521


Locations
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Russian Federation
Sandoz Investigational Site
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
Sponsors and Collaborators
Sandoz
Investigators
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Study Director: Sandoz Sandoz
  Study Documents (Full-Text)

Documents provided by Sandoz:
Study Protocol  [PDF] September 28, 2016
Statistical Analysis Plan  [PDF] February 15, 2017


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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT03095521     History of Changes
Other Study ID Numbers: TE_004_ANG_LOZ
First Posted: March 29, 2017    Key Record Dates
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandoz:
Angal
ANTI-ANGIN® FORMULA
sore throat
no less therapeutic efficacy

Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Menthol
Antipruritics
Dermatologic Agents