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

Sandoz

Status and phase: Completed; Phase 3

Conditions: Sore Throat

Treatments: Drug: ANTI-ANGIN® FORMULA; Drug: Angal, lozenges [menthol],

Study type: Interventional

Funder types: Industry

Identifiers

NCT03095521

TE_004_ANG_LOZ

Details and patient eligibility

About

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.

Enrollment: 228 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Arm A

Experimental group

Description:

Angal, lozenges, 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, if this will happen earlier than 4th day of treatment.

Treatment:

Drug: Angal, lozenges [menthol],

Arm B

Active Comparator group

Description:

ANTIANGIN ® FORMULA, 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, if this will happen earlier than 5th day of treatment.

Treatment:

Drug: ANTI-ANGIN® FORMULA