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Phase 3 N=229 Randomized Treatment

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

Sore Throat

Enrolled (actual)
229
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) — 89.47; 75.65; 7.02; 19.13 Percentage of Participants — p=0.00001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Angal S, topical spray [Menthol] (Drug); ANTI-ANGIN® FORMULA, topical metered spray (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Sandoz
Primary completion
May 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)
89.47; 75.65; 7.02; 19.13; 2.63; 4.35 0.00001 sig
SECONDARY
Percentage of Participants With a ≥50% TSS Total Score Reduction
96.49; 98.26 0.446
SECONDARY
Change From Baseline in TSS Total Score
-6; -6
SECONDARY
Number of Participants Who Fully Recovered
106; 107 1.0
SECONDARY
Change in the Sore Throat Intensity by 100 mm VAS
64.76; 65.84; 2.99; 5.06 0.145
SECONDARY
Period of Time Required for Disappearance of the Disease Symptoms
3.75; 3.94 0.188

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03095508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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