A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (NCT03827655) | Clinical Trial Compass
CompletedPhase 2
A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery
United States209 participantsStarted 2019-03-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or large-bowel resection.
✓. Participant's American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3.
Exclusion criteria
✕. 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.
✕. Had previous major abdominal surgery (example, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).
✕. Had a history of radiation therapy to the abdomen or pelvis.
✕. 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 \[sigmoid colon and above\]).
✕. 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).
What they're measuring
1
Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator
Timeframe: Day 1 (surgery) up to Day 10 postsurgery
✕. Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride, or azithromycin in the 24 hours prior to starting study drug.
✕. Participant has known COVID-19 infection, or suspected COVID-19 infection.
✕. Scheduled for abdominal surgery that is classified as emergency.