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

NCT03095508 | Completed Phase 3 Results

• 1 other identifier: TE_003_ANG_LSP
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 14

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

Keywords

Angal S; ANTI-ANGIN FORMULA; Sore Throat; no less therapeutic efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of Participants With a ≥50% TSS Total Score Reduction

  4 days

• Change From Baseline in TSS Total Score

  4 days

• Number of Participants Who Fully Recovered

  Group A: 4 days Group B: 5 days

• Change in the Sore Throat Intensity by 100 mm VAS

  4 days

• Period of Time Required for Disappearance of the Disease Symptoms

  5 Days

Study Arms (2)

Angal S (Arm A)

EXPERIMENTAL

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]

ANTI-ANGIN® FORMULA (Arm B)

ACTIVE COMPARATOR

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

Interventions

Angal S, topical spray [Menthol] 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

Angal S (Arm A)

ANTI-ANGIN® FORMULA, topical metered spray 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

ANTI-ANGIN® FORMULA (Arm B)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily signed informed consent for participation in this clinical study;
• to 45 years old inclusive, male and female;
• Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat;
• Body temperature 37,5 C (axillary).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sandoz: lead

Study Sites (14)

Sandoz Investigational Site

Arkhangelsk, 163000, Russia

Location

Sandoz Investigational Site

Moscow, 105018, Russia

Location

Sandoz Investigational Site

Moscow, 115280, Russia

Location

Sandoz Investigational Site

Moscow, 119192, Russia

Location

Sandoz Investigational Site

Moscow, 127015, Russia

Location

Sandoz Investigational Site

Moscow, 135215, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 188643, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 191036, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 196143, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 197706, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 198207, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 199178, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 199226, Russia

Location

Sandoz Investigational Site

Stavropol, 355000, Russia

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Menthol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Results Point of Contact

• Title: Study Director
• Organization: Sandoz

Sandoz.email@sandoz.com

+41613241111

Study Officials

• Sandoz

  Sandoz

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: March 29, 2017
• Study Start: February 22, 2017
• Primary Completion: May 8, 2017
• Study Completion: May 8, 2017
• Last Updated: March 21, 2019
• Results First Posted: March 21, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (14)