NCT03827655

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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).

Conditions

• Postoperative Gastrointestinal Dysfunction

Interventions

Type	Name	Description
DRUG	TAK-954 Placebo	TAK-954 placebo-matching intravenous infusion.
DRUG	TAK-954	TAK-954 intravenous infusion.

Timeline

• Start date: 2019-03-07
• Primary completion: 2022-05-27
• Completion: 2022-05-27
• First posted: 2019-02-01
• Last updated: 2023-06-23
• Results posted: 2023-06-23

Locations

25 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study