Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Joseph Carmichael

Description

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection

Details

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 undergoing open or laparoscopic-assisted partial small- or large-bowel resection. In addition, some participants will also receive TAK-954 postoperatively to evaluate if there is an additional benefit when this drug is administered both pre and post-surgery. The study will enroll approximately 180 participants. Participants will be equally randomized into one of the three remaining parallel treatment arms- which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). All participants will be given intravenous infusion preoperation and daily postoperation until return of upper and lower GI function or for up to 10 days. This multi-center trial will be conducted in the United States and Germany. The overall time to participate in this study is up to 100 days. Participants will be treated with the study drug for up to 10 days after surgery or until return of GI function post-surgery (whichever occurs first).

Keywords

Postoperative Gastrointestinal Dysfunction Drug Therapy TAK-954 TAK-954 0.5 mg/100 mL

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Parkview Community Hospital Medical Center completed
    Riverside California 92504 United States

Lead Scientist at UC Irvine

  • Joseph Carmichael
    Associate Clinical Professor, Surgery. Authored (or co-authored) 112 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
Links
To obtain more information on the study, click here/on this link.
ID
NCT03827655
Phase
Phase 2
Study Type
Interventional
Last Updated