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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03095508 | 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 | PHASE3 | COMPLETED | 229 | — | — | Feb 22, 2017 | May 8, 2017 | Mar 21, 2019 | 14 | Russia |
The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15.
| Arm | Type | Description |
|---|---|---|
| Angal S (Arm A) | EXPERIMENTAL | Patients received Angal S, topical spray \[Menthol\], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
| ANTI-ANGIN® FORMULA (Arm B) | ACTIVE_COMPARATOR | Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
| Name | Type | Description |
|---|---|---|
| Angal S, topical spray [Menthol] | DRUG | 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
| ANTI-ANGIN® FORMULA, topical metered spray | DRUG | 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as one to two consecutive presses on the actuator button, up to 6 times 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 un...