TAK-954 in Critically Ill Patients with Enteral Feeding Intolerance
Research type
Research Study
Full 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
IRAS ID
240364
Contact name
Tamas Szakmany
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc. a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
Eudract number
2017-003206-41
Clinicaltrials.gov Identifier
114408, IND Number
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Tube feeding is a way of providing nutrition to patients who cannot eat or drink at the time. It involves a narrow tube being inserted through the nose or mouth directly to the stomach or gut. This means food is not chewed (as it bypasses the mouth) and can sit in the stomach too long instead of being digested and absorbed properly in the gut. This may cause bloating, cramps, sickness, nausea, regurgitation, constipation and diarrhoea. This is called Enteral Feeding Intolerance (EFI).
EFI, and as a result, malnourishment in critically ill patients is associated with impaired immune system, increased infection risk, prolonged need for ventilation, increased intensive care (ICU) stays and higher mortality. Current treatments for EFI primarily target the upper small bowel and stomach, yet the whole gastrointestinal (GI) tract is affected by EFI. A treatment that targets more than just the upper GI track would be beneficial.
TAK-954 is being developed for short term treatment of patients with EFI. Evidence shows TAK-954 activity throughout the GI tract.
This study involves the administration of TAK-954 or metoclopramide (commonly used for treatment for EFI) to approx. 200 participants in 40 hospitals in Australia, Canada, the UK and the USA.
Participants will be ventilated and in the ICU and will have been diagnosed with EFI. They will be randomised (like flipping a coin) to take either 1 of 3 doses of TAK-954 or to take metoclopramide. The study is double blind, so the sponsor, hospital team nor the participant will know what they are receiving. The participants will take the assigned medication for 5 to 14 days. A follow up examination (3 days after treatment) and telephone check-up (90 days after treatment) will occur. During the study participants will undergo various procedures, administration of study medication and assessments.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0139
Date of REC Opinion
29 May 2018
REC opinion
Further Information Favourable Opinion