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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

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ClinicalTrials.gov Identifier: NCT03095508
Recruitment Status : Completed
First Posted : March 29, 2017
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Sandoz

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sore Throat Drug: Angal S, topical spray [Menthol] Drug: ANTI-ANGIN® FORMULA, topical metered spray Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : May 8, 2017
Actual Study Completion Date : May 8, 2017

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
Experimental: Angal S (Arm A)
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
 Drug: 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
Active Comparator: ANTI-ANGIN® FORMULA (Arm B)
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
 Drug: ANTI-ANGIN® FORMULA, topical metered spray
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) [ Time Frame: 4 Days ]

    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 :
  1. Percentage of Participants With a ≥50% TSS Total Score Reduction [ Time Frame: 4 days ]

    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.


  2. Change From Baseline in TSS Total Score [ Time Frame: 4 days ]

    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.


  3. Number of Participants Who Fully Recovered [ Time Frame: Group A: 4 days Group B: 5 days ]
    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)

  4. Change in the Sore Throat Intensity by 100 mm VAS [ Time Frame: 4 days ]
    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.

  5. Period of Time Required for Disappearance of the Disease Symptoms [ Time Frame: 5 Days ]
    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.


Eligibility Criteria
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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);
  • 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).
Contacts and Locations
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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): NCT03095508


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 29, 2016
Statistical Analysis Plan  [PDF] February 15, 2017

More Information
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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT03095508    
Other Study ID Numbers: TE_003_ANG_LSP
First Posted: March 29, 2017    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: March 21, 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 S
ANTI-ANGIN FORMULA
Sore Throat
no less therapeutic efficacy
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Infections
Respiratory Tract Infections
Stomatognathic Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Menthol
Antipruritics
Dermatologic Agents