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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03463512 | Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea | PHASE3 | COMPLETED | 124 | — | — | Mar 29, 2018 | Sep 10, 2018 | Oct 23, 2019 | 1 | Russia |
Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary. Log-rank test was performed with a p-value \< 0.0001
| Arm | Type | Description |
|---|---|---|
| Racecadotril plus standard treatment oral rehydration solution | EXPERIMENTAL | - |
| ORS (standard treatment) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Racecadotril plus ORS | DRUG | Racecadotril plus ORS |
| ORS | DRUG | ORS |
Inclusion Criteria: * Signed informed consent from one of the parent(s)/caregiver(s) or subject informed assent * Children and adolescents, both genders, age from 3 months to \< 18 years of age * Confirmed diagnosis of acute diarrhea (defined as the passage of three or more unformed or liquid stool...