Status:
COMPLETED
A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery
Lead Sponsor:
Takeda
Collaborating Sponsors:
Takeda Development Center Americas, Inc.
Conditions:
Postoperative Gastrointestinal Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Participant...
Detailed Description
The drug being tested in this study is called TAK-954. In this study TAK-954 is being administered presurgery to evaluate if it can enhance the recovery of GI function postsurgery in participants unde...
Eligibility Criteria
Inclusion
- 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
- 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).
- 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.
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT03827655
Start Date
March 7 2019
End Date
May 27 2022
Last Update
June 23 2023
Active Locations (25)
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1
University of South Alabama Medical Center
Mobile, Alabama, United States, 30617
2
Keck School of Medicine
Los Angeles, California, United States, 90007
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
University of California Irvine Medical Center
Orange, California, United States, 92868