NCT03095521

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

A Prospective, Multi-center, Open, Randomized Clinical Study in Parallel Groups, for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol], 1 mg + 5 mg (Sandoz d.d., Slovenia), and 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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sore Throat

Interventions

Type	Name	Description
DRUG	Angal, lozenges [menthol],	Angal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution.
DRUG	ANTI-ANGIN® FORMULA	0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution.

Timeline

• Start date: 2017-02-22
• Primary completion: 2017-05-07
• Completion: 2017-05-07
• First posted: 2017-03-29
• Last updated: 2019-03-22
• Results posted: 2019-03-22

Locations

14 sites across 1 country: Russia