A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat

NCT03095521 | Completed Phase 3 Results

• 1 other identifier: TE_004_ANG_LOZ
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal, lozenges \[Menthol\], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, lozenges, 0,2 mg + 2 mg + 50 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; ANTI-ANGIN® FORMULA; sore throat; no less therapeutic efficacy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Without Sore Throat According to TSS Score

  TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : \<37.5 °С; 1. pts : 37.5 to \<38.5 °С; 2. pts : 38.5 to \<39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.

  4 days

Secondary Outcomes (5)

• 50% Reduction Tss SCORE

  day 4

• Change From Baseline in TSS Total Score

  baseline and day 4

• Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)

  5 days

• Number of Participants Who Fully Recovered up to Day 5

  4 days for Angal, 5 days for AntiAngin

• Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) .

  baseline, day 4

Study Arms (2)

Arm A

EXPERIMENTAL

Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if this will happen earlier than 4th day of treatment.

Drug: Angal, lozenges [menthol],

Arm B

ACTIVE COMPARATOR

ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if this will happen earlier than 5th day of treatment.

Drug: ANTI-ANGIN® FORMULA

Interventions

Angal, lozenges [menthol], DRUG

Angal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution.

Arm A

ANTI-ANGIN® FORMULA DRUG

0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution.

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; 18 to 45 years old inclusive, male and female;
• Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat;
• Baseline TSS score (Tonsillopharyngitis Severity Score) ≥ 5 (total score);

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 21, 2017
• First Posted: March 29, 2017
• Study Start: February 22, 2017
• Primary Completion: May 7, 2017
• Study Completion: May 7, 2017
• Last Updated: March 22, 2019
• Results First Posted: March 22, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (14)