drugset / Trial / NCT04557189

A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery

NCT04557189

Phase 2 Completed 89 enrolled Takeda
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Some adults are at a higher risk of feeling sick (nausea) or being sick (vomiting) after they have surgery. In this study, these adults will have planned surgery. The main aim of this study is to learn if TAK-951 stops these adults from getting nausea or vomiting after surgery. This will be compared with another medicine called ondansetron. Another aim is to check for side effects from the study medicines. Before surgery, the study doctor will check who can take part in this study. Those who can take part will be picked for either Treatment Group A or Treatment Group B by chance. * Treatment Group A: Just before surgery, participants will receive a placebo slowly through a vein (infusion). Just before the end of the surgery, they will receive TAK-951 as an injection under the skin. * Treatment Group B: Just before surgery, participants will receive ondansetron slowly through a vein (infusion). Just before the end of the surgery, they will receive a placebo as an injection under the skin. In this study, a placebo will look like TAK-951 but will not have any medicine in it. Participants will not know which study medicines they received, or in which order, nor will their study doctors or surgeons. This is to help make sure the results are more reliable. Participants will stay in the hospital for 24 hours after their surgery so that the study doctors can check for nausea and vomiting. The study doctors will also check for side effects from the study medicines. Participants will visit the hospital for a check-up 14 days later.

Timeline

Start
2020-10-20
Primary completion
2022-03-07
Completion
2022-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Ondansetron Other / unclassified 4 mg Intravenous
Subject TAK-951 Unknown 4 mg Subcutaneous

Indications

No indication recorded.