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

Sore Throat Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095508
• Other study ID #: TE_003_ANG_LSP
• Status: Completed
• Phase: Phase 3
• Start date: February 22, 2017
• Est. completion date: May 8, 2017

Study information

• Verified date: December 2018
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: May 8, 2017
• Est. primary completion date: May 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pharyngeal Diseases
• Pharyngitis
• Sore Throat

Intervention

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
• 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

Locations

Country	Name	City	State
Russian Federation	Sandoz Investigational Site	Arkhangel'sk
Russian Federation	Sandoz Investigational Site	Moscow
Russian Federation	Sandoz Investigational Site	Moscow
Russian Federation	Sandoz Investigational Site	Moscow
Russian Federation	Sandoz Investigational Site	Moscow
Russian Federation	Sandoz Investigational Site	Moscow
Russian Federation	Sandoz Investigational Site	Saint Petersburg
Russian Federation	Sandoz Investigational Site	Saint Petersburg
Russian Federation	Sandoz Investigational Site	Saint Petersburg
Russian Federation	Sandoz Investigational Site	Saint Petersburg
Russian Federation	Sandoz Investigational Site	Saint Petersburg
Russian Federation	Sandoz Investigational Site	Saint Petersburg
Russian Federation	Sandoz Investigational Site	Saint Petersburg
Russian Federation	Sandoz Investigational Site	Stavropol'

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 Days
Secondary	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.	4 days
Secondary	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.	4 days
Secondary	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)	Group A: 4 days Group B: 5 days
Secondary	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.	4 days
Secondary	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.	5 Days