Phase 3
N=228
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
Bottom Line
View on ClinicalTrials.gov: NCT03095521 ↗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
| Outcome | Result | p-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);
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.