A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery

Completed · Phase 2 · Has a placebo group

Conditions studied: Postoperative Gastrointestinal Dysfunction

In brief

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.

Key facts

Study ID

NCT03827655

Run by

Takeda

People needed

209

Starts

2019-03-07

Expected to finish

2022-05-27

Last updated by the study team

2023-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of South Alabama Medical Center — Mobile, Alabama, United States
• Keck School of Medicine — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Parkview Community Hospital Medical Center — Riverside, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Miami Leonard M. Miller School of Medicine — Miami, Florida, United States
• Center for Colon & Rectal Surgery - Altamonte Springs — Orlando, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Fairview Hospital — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• HD Research Corp. — Houston, Texas, United States
• North Star Medical — Houston, Texas, United States
• Universitatsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• Universitatsklinikum Mannheim — Mannheim, Baden-Wurttemberg, Germany
• Klinikum Rechts der Isar der Technischen Universitat Munchen — München, Bavaria, Germany
• Universitaetsklinikum Regensburg — Regensburg, Bavaria, Germany
• Sankt Josef-Hospital — Bochum, North Rhine-Westphalia, Germany
• Universitaetsklinikum Hamburg-Eppendorf — Hamburg, Germany

Full record on ClinicalTrials.gov

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