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Phase 3 N=228 Randomized Treatment

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

Sore Throat

Enrolled (actual)
228
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Percentage of Participants Without Sore Throat According to TSS Score — 84.35; 73.21; 13.91; 17.86 percentage of participants — p=0.028

Study Design & Population

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Without Sore Throat According to TSS Score
84.35; 73.21; 13.91; 17.86; 1.74; 8.93 0.028 sig
SECONDARY
50% Reduction Tss SCORE
97.35; 98.13
SECONDARY
Change From Baseline in TSS Total Score
6.88; 7.03; 0.45; 0.83
SECONDARY
Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)
3.75; 3.93 0.482
SECONDARY
Number of Participants Who Fully Recovered up to Day 5
102; 104
SECONDARY
Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) .
66.38; 66.99; 2.35; 4.67 0.072

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);
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03095521). 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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