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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

Primary Purpose

Sore Throat

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Angal S, topical spray [Menthol]
ANTI-ANGIN® FORMULA, topical metered spray
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sore Throat focused on measuring Angal S, ANTI-ANGIN FORMULA, Sore Throat, no less therapeutic efficacy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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).

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

Angal S (Arm A)

ANTI-ANGIN® FORMULA (Arm B)

Arm Description

Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution

Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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)
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.
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.

Full Information

First Posted
March 24, 2017
Last Updated
December 14, 2018
Sponsor
Sandoz
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1. Study Identification

Unique Protocol Identification Number
NCT03095508
Brief Title
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
Official Title
Prospective, Multicenter, Open, Randomized, Parallel, Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray [Menthol], 0,5 mg + 2 mg / 1 ml (Sandoz d.d., Slovenia), and ANTI-ANGIN® FORMULA, Topical Metered Spray, 0,12 mg + 0,24 mg / Dose (OOO "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 8, 2017 (Actual)
Study Completion Date
May 8, 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
Keywords
Angal S, 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
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angal S (Arm A)
Arm Type
Experimental
Arm Description
Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
Arm Title
ANTI-ANGIN® FORMULA (Arm B)
Arm Type
Active Comparator
Arm Description
Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
Intervention Type
Drug
Intervention Name(s)
Angal S, topical spray [Menthol]
Intervention Description
0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
Intervention Type
Drug
Intervention Name(s)
ANTI-ANGIN® FORMULA, topical metered spray
Intervention Description
0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as one to two consecutive presses on the actuator button, up to 6 times per day, , for a maximum 5 days or until full illness resolution
Primary Outcome Measure Information:
Title
Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)
Description
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 Outcome Measure Information:
Title
Percentage of Participants With a ≥50% TSS Total Score Reduction
Description
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
Title
Change From Baseline in TSS Total Score
Description
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
Title
Number of Participants Who Fully Recovered
Description
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
Title
Change in the Sore Throat Intensity by 100 mm VAS
Description
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
Title
Period of Time Required for Disappearance of the Disease Symptoms
Description
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

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); 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).
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

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

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