A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery
Condition: Postoperative Gastrointestinal Dysfunction
Intervention: TAK-954 Placebo; TAK-954
Intervention description: TAK-954 placebo-matching intravenous infusion.; TAK-954 intravenous infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

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.
    

Eligibility criteria:

        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 obstruction that is not expected to resolve after the
             surgery, short bowel syndrome, pre-existing clinically significant GI motility
             disorder (example, gastroparesis, scleroderma, chronic intestinal pseudo-obstruction),
             uncontrolled diabetes (glycosylated hemoglobin [HbA1c] greater than [>] 10 percent
             [%]), has an active gastric pacemaker, or requires parenteral nutrition.

          2. Had previous major abdominal surgery (example, gastrectomy, gastric bypass, gastric
             sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy,
             hemicolectomy, extensive bowel resection).

          3. Had a history of radiation therapy to the abdomen or pelvis.

          4. Scheduled to undergo any of the following surgeries: low anterior resection, total or
             subtotal colectomy, colostomy, ileostomy or reversal of stoma, or has a diagnosis that
             requires rectal resection (eg, tumors in the anorectum) and will likely require lower
             anterior resection surgery. Participants with planned surgery for which there is no
             anticipated significant rectal resection and is, therefore, likely to preserve
             anorectal function and continence postsurgery, will likely be eligible for inclusion
             in the study if they meet all the study inclusion/exclusion criteria (eg, participants
             with lesions not involving the rectum [sigmoid colon and above]).

          5. Has pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score
             7 to 9 points) or C (severe; total score 10 to 15 points).

          6. Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone,
             cisapride, mosapride, renzapride, or azithromycin in the 24 hours prior to starting
             study drug.

          7. Participant has known COVID-19 infection, or suspected COVID-19 infection.

          8. Scheduled for abdominal surgery that is classified as emergency.