Phase 3
N=229
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
Bottom Line
View on ClinicalTrials.gov: NCT03095508 ↗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
| Outcome | Result | p-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).
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.