Clinical trial NCT03095521: 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
Official title: A Prospective, Multi-center, Open, Randomized Clinical Study in Parallel Groups, for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol], 1 mg + 5 mg (Sandoz d.d., Slovenia), and 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sore Throat
Keywords: Angal
ANTI-ANGIN® FORMULA
sore throat
no less therapeutic efficacy
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2017-03-29
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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);

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);

Primary outcomes:
measure: Percentage of Participants Without Sore Throat According to TSS Score
timeFrame: 4 days
Secondary outcomes:
measure: 50% Reduction Tss SCORE
timeFrame: day 4
measure: Change From Baseline in TSS Total Score
timeFrame: baseline and day 4
measure: Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)
timeFrame: 5 days
measure: Number of Participants Who Fully Recovered up to Day 5
timeFrame: 4 days for Angal, 5 days for AntiAngin
measure: Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) .
timeFrame: baseline, day 4
Other outcomes:
Locations:
city: Arkhangel'sk
country: Russian Federation
facility: Sandoz Investigational Site
city: Moscow
country: Russian Federation
facility: Sandoz Investigational Site
city: Moscow
country: Russian Federation
facility: Sandoz Investigational Site
city: Moscow
country: Russian Federation
facility: Sandoz Investigational Site
city: Moscow
country: Russian Federation
facility: Sandoz Investigational Site
city: Moscow
country: Russian Federation
facility: Sandoz Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Sandoz Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Sandoz Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Sandoz Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Sandoz Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Sandoz Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Sandoz Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Sandoz Investigational Site
city: Stavropol'
country: Russian Federation
facility: Sandoz Investigational Site
Study officials:
affiliation: Sandoz
name: Sandoz
role: STUDY_DIRECTOR
References: