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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03583658 | Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis | PHASE3 | COMPLETED | 390 | — | — | Jun 30, 2018 | Sep 2, 2018 | Apr 25, 2022 | 1 | South Africa |
Change from baseline to hour 3 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-3h)
| Arm | Type | Description |
|---|---|---|
| Ambroxol hydrochloride (BIH1526) | ACTIVE_COMPARATOR | One lozenge 20 mg on as-needed basis, up to 6 times per day |
| Placebo | PLACEBO_COMPARATOR | One lozenge on as-needed basis, up to 6 times per day |
| Name | Type | Description |
|---|---|---|
| ambroxol BIH1526 | DRUG | Pharmaceutical form: lozenges Route of administration: oromucosal |
| placebo | DRUG | Pharmaceutical form: lozenges Route of administration: oromucosal |
Inclusion criteria: * Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1. * Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale. * Signed written informed consent. Exclusion ...