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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04557189 | A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery | PHASE2 | COMPLETED | 89 | — | — | Oct 20, 2020 | Mar 21, 2022 | Apr 21, 2023 | 7 | United States |
Percentage of participants with complete response, defined as no emesis (vomiting or retching) and no need for rescue therapy (indicated if vomiting/retching and/or nausea score ≥4 or upon participant's request) were reported. The severity of nausea was scored using a self-reported, 11-point numerical Verbal Rating Scale (VRS), where 0 represents no nausea and 10 represents the worst nausea possible. Significant nausea was defined as a VRS score ≥4. Percentages are rounded off to whole number at the nearest single decimal.
| Arm | Type | Description |
|---|---|---|
| Ondansetron 4 mg IV | EXPERIMENTAL | Participants received prophylaxis with ondansetron 4 mg, intravenously (IV) immediately before induction and TAK-951 placebo subcutaneously (SC) approximately 30 to 45 minutes before the end of surgery (wound closure). |
| TAK-951 4 mg SC | EXPERIMENTAL | Participants received prophylaxis with ondansetron placebo IV immediately before induction and TAK 951 4 mg, SC, approximately 30 to 45 minutes before the end of surgery (wound closure). |
| Name | Type | Description |
|---|---|---|
| TAK-951 | DRUG | TAK-951 SC injection |
| Ondansetron | DRUG | Ondansetron IV injection |
| Ondansetron Placebo | DRUG | Ondansetron placebo-matching IV injection |
| TAK-951 Placebo | DRUG | TAK-951 placebo-matching SC injection |
Inclusion Criteria: 1. Participants undergoing elective surgery under general anesthesia, expected to last for at least 1 hour from induction of anesthesia to wound closure. 2. Participants are expected to require or have agreed to stay, at least 1 overnight in the hospital. 3. Participants America...