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

NCT ID: NCT03095508

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2017-05-08

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.

Conditions

Sore Throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Angal S, topical spray [Menthol]

Intervention Type: DRUG

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 (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

Group Type: ACTIVE_COMPARATOR

ANTI-ANGIN® FORMULA, topical metered spray

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandoz

Role: STUDY_DIRECTOR

Sandoz

Locations

Sandoz Investigational Site

Arkhangelsk, , Russia

Sandoz Investigational Site

Moscow, , Russia

Sandoz Investigational Site

Moscow, , Russia

Sandoz Investigational Site

Moscow, , Russia

Sandoz Investigational Site

Moscow, , Russia

Sandoz Investigational Site

Moscow, , Russia

Sandoz Investigational Site

Saint Petersburg, , Russia

Sandoz Investigational Site

Saint Petersburg, , Russia

Sandoz Investigational Site

Saint Petersburg, , Russia

Sandoz Investigational Site

Saint Petersburg, , Russia

Sandoz Investigational Site

Saint Petersburg, , Russia

Sandoz Investigational Site

Saint Petersburg, , Russia

Sandoz Investigational Site

Saint Petersburg, , Russia

Sandoz Investigational Site

Stavropol, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TE_003_ANG_LSP

Identifier Type: -

Identifier Source: org_study_id