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
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.
Timeline
- Start
- 2017-02-22
- Primary completion
- 2017-05-08
- Completion
- 2017-05-08
Outcome
Met primary endpoint
registry NUMBER Angal S (Arm A): Score 0 (no sore throat): 89.47 Percentage of Participants NCT03095508 ↗
registry analysis (non-inferiority test); Angal S (Arm A) vs ANTI-ANGIN® FORMULA (Arm B); p = 0.00001; Risk Difference (RD) 0.14 (95% CI 0.03 to 0.24); Fisher Exact; note: p- value for superiority: 0.021 NCT03095508 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ANTI-ANGIN® FORMULA | Unknown | 0.12 mg | Topical |
| Comparator | ANTI-ANGIN® FORMULA | Unknown | 0.24 mg | Topical |
| Subject | Angal S | Unknown | 0.5 mg | Topical |
| Subject | Angal S | Unknown | 2 mg | Topical |