drugset / Trial / NCT03827655
A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main aim of this study is to check for side effects from TAK-954 and whether it speeds up the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery. Participants will be treated with TAK-954 before surgery and up to 10 days after surgery.
Timeline
- Start
- 2019-03-07
- Primary completion
- 2022-05-27
- Completion
- 2022-05-27
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs TAK-954 0.5 mg/100 mL; p =0.649; Hazard Ratio (HR) 0.92 (90% CI 0.63 to 1.33) NCT03827655 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | felcisetrag | Small molecule | 0.001 mg/ml | Intravenous |
| Subject | felcisetrag | Small molecule | 0.005 mg/ml | Intravenous |