NCT03477903

TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)

A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Intolerance

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the treatment effect of intravenous TAK-954 in improving the average daily protein adequacy received through enteral nutrition in critically-ill participants developing EFI.

Detailed description

The drug being tested in this study is called TAK-954. The study will assess the treatment effect of intravenous TAK-954 in improving average daily protein adequacy received through enteral nutrition in critically ill participants with EFI. The study will enroll approximately 200 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment groups -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Group A: TAK-954 0.1 mg * Group B: TAK-954 0.3 mg * Group C: TAK-954 1 mg * Group D: Metoclopramide 10 mg This multi-center trial will be conducted in the United States, United Kingdom, Australia and Canada. The overall duration of treatment in this study is maximum of 14 days while in hospital. Participants will be contacted by telephone 30 and 90 days after receiving their last dose of study drug for a follow-up assessment.

Conditions

• Critical Illness
• Enteral Nutrition
• Enteral Feeding Intolerance

Interventions

Type	Name	Description
DRUG	TAK-954	TAK-954 infusion
DRUG	Metoclopramide	Metoclopramide infusion
DRUG	Normal Saline	0.9% sodium chloride for injection

Timeline

• Start date: 2018-08-25
• Primary completion: 2018-08-29
• Completion: 2018-08-29
• First posted: 2018-03-27
• Last updated: 2019-09-24
• Results posted: 2019-09-24

Locations

44 sites across 4 countries: United States, Australia, Canada, United Kingdom

Regulatory

• FDA-regulated drug study