Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | COMPLETED | 228 | — | — | Feb 22, 2017 | May 7, 2017 | Mar 22, 2019 | 14 | Russia |
TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : \<37.5 °С; 1. pts : 37.5 to \<38.5 °С; 2. pts : 38.5 to \<39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | 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. |
| Arm B | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Angal, lozenges [menthol], | DRUG | 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. |
| ANTI-ANGIN® FORMULA | DRUG | 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. |
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 unco...