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
Primary Purpose
Sore Throat
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Angal, lozenges [menthol],
ANTI-ANGIN® FORMULA
Sponsored by
About this trial
This is an interventional treatment trial for Sore Throat focused on measuring Angal, ANTI-ANGIN® FORMULA, sore throat, no less therapeutic efficacy
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);
Sites / Locations
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
- Sandoz Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03095521
Brief Title
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
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
May 7, 2017 (Actual)
Study Completion Date
May 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
Keywords
Angal, ANTI-ANGIN® FORMULA, sore throat, no less therapeutic efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Angal, lozenges [menthol],
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ANTI-ANGIN® FORMULA
Intervention Description
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 Measure Information:
Title
Percentage of Participants Without Sore Throat According to TSS Score
Description
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.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
50% Reduction Tss SCORE
Description
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
Time Frame
day 4
Title
Change From Baseline in TSS Total Score
Description
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.
Time Frame
baseline and day 4
Title
Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)
Description
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
Time Frame
5 days
Title
Number of Participants Who Fully Recovered up to Day 5
Description
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)
Time Frame
4 days for Angal, 5 days for AntiAngin
Title
Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) .
Description
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
baseline, day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandoz
Organizational Affiliation
Sandoz
Official's Role
Study Director
Facility Information:
Facility Name
Sandoz Investigational Site
City
Arkhangel'sk
ZIP/Postal Code
163000
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Moscow
ZIP/Postal Code
105018
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Moscow
ZIP/Postal Code
119192
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Moscow
ZIP/Postal Code
135215
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Saint Petersburg
ZIP/Postal Code
188643
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Saint Petersburg
ZIP/Postal Code
191036
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Saint Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Saint Petersburg
ZIP/Postal Code
198207
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Saint Petersburg
ZIP/Postal Code
199178
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Saint Petersburg
ZIP/Postal Code
199226
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Stavropol'
ZIP/Postal Code
355000
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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