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

Critical Illness Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03477903
Study type Interventional
Source Takeda
Contact
Status Terminated
Phase Phase 2
Start date August 25, 2018
Completion date August 29, 2018
View Details
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