Clinical trial NCT03095508: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sore Throat
Keywords: Angal S
ANTI-ANGIN FORMULA
Sore Throat
no less therapeutic efficacy
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2017-03-29
Enrollment: 229
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 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.


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).

Primary outcomes:
measure: Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)
timeFrame: 4 Days
Secondary outcomes:
measure: Percentage of Participants With a ≥50% TSS Total Score Reduction
timeFrame: 4 days
measure: Change From Baseline in TSS Total Score
timeFrame: 4 days
measure: Number of Participants Who Fully Recovered
timeFrame: Group A: 4 days Group B: 5 days
measure: Change in the Sore Throat Intensity by 100 mm VAS
timeFrame: 4 days
measure: Period of Time Required for Disappearance of the Disease Symptoms
timeFrame: 5 Days
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: