Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and AN… (NCT03095508) | Clinical Trial Compass
CompletedPhase 3
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
Russia229 participantsStarted 2017-02-22
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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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).
What they're measuring
1
Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)