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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03827655 | A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery | PHASE2 | COMPLETED | 209 | — | — | Mar 7, 2019 | May 27, 2022 | Jun 23, 2023 | 25 | United States, Germany |
The time from end of surgery to tolerance of solid food, without first occurrence of vomiting or clinically significant nausea for 1 calendar day after a solid meal (upper GI function) and first spontaneous bowel movement (lower GI function), whichever occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. |
| TAK-954 0.1 mg/100 mL | EXPERIMENTAL | TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. |
| TAK-954 0.5 mg/100 mL | EXPERIMENTAL | TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. |
| TAK-954 0.1 mg/100 mL + Placebo | EXPERIMENTAL | TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function. |
| TAK-954 0.5 mg/100 mL + Placebo | EXPERIMENTAL | TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function. |
| Name | Type | Description |
|---|---|---|
| TAK-954 Placebo | DRUG | TAK-954 placebo-matching intravenous infusion. |
| TAK-954 | DRUG | TAK-954 intravenous infusion. |
Inclusion Criteria: 1. Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or large-bowel resection. 2. Participant's American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3. Exclusion Criteria: 1. Has significant mechanical bowel ob...