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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02246439 | BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis | PHASE3 | COMPLETED | 330 | — | — | Dec 8, 2014 | Feb 16, 2017 | Feb 20, 2019 | 26 | United States |
Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
| Arm | Type | Description |
|---|---|---|
| RHB-102 | EXPERIMENTAL | RHB-102, Bimodal Release Ondansetron Tablets |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| RHB-102 | DRUG | RHB-102, Bimodal Release Ondansetron Tablets |
| Placebo Oral Tablet | DRUG | Placebo |
Inclusion Criteria: * Patients must have vomited at least twice in the 4 hours preceding signing informed consent. A vomiting episode is defined as an episode of forceful expulsion of stomach contents. Retching if a patient has already emptied his or her gastric contents is also considered vomiting...