Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The purpose of this study is to assess the efficacy and safety of intravenous (IV) TAK-954 for accelerating the recovery of gastrointestinal (GI) function postsurgery in participants undergoing open or laparoscopic-assisted partial small- or large-bowel resection.

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 gastrointestinal (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 375 patients. Participants will be randomly assigned in 1:1:1:1:1 ratio to one of the five treatment arms—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need).

All participants will be given IV 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 North America and Europe. 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 after return of GI function post-surgery (whichever occurs first).

Keywords

Postoperative Gastrointestinal Dysfunction Drug Therapy TAK-954 TAK-954 0.1 mg/100 mL 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.

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 (eg, gastroparesis, scleroderma, chronic intestinal pseudo-obstruction), uncontrolled diabetes (glycosylated hemoglobin [HbA1c] >10%), has an active gastric pacemaker, or requires parenteral nutrition.
  2. Had previous major abdominal surgery (eg, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).
  3. Scheduled to undergo any of the following surgeries: low anterior resection, total or subtotal colectomy, colostomy, ileostomy or reversal of stoma.
  4. 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).
  5. Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, or azithromycin in the 24 hours prior to surgery or during the study period.
  6. Had a history of radiation therapy to the abdomen or pelvis.

Locations

  • University of California San Diego Moores Cancer Center not yet accepting patients
    La Jolla California 92037 United States
  • Parkview Community Hospital accepting new patients
    Riverside California 92503 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Millennium Pharmaceuticals, Inc.
ID
NCT03827655
Phase
Phase 2
Study Type
Interventional
Last Updated