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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
TAK-954 infusion
Metoclopramide infusion
0.9% sodium chloride for injection
Average Daily Protein Adequacy Over the First 5 Days of Treatment
Average daily protein adequacy received through enteral nutrition is defined as the percentage of goal protein delivered per day, where percentage of goal protein delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 5 days was averaged.
Time frame: Days 1 to 5
Average Daily Protein Adequacy Over the Study Treatment Period
Average daily protein adequacy received through enteral nutrition is defined as percentage of goal protein delivered per day, where percentage of protein goal delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 14 days was averaged.
Time frame: Days 1 to 14
Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment
GRV is defined as the volume of fluid remaining in the stomach at a point in time during enteral nutrition feeding. The value for each of the 5 days was averaged.
Time frame: Days 1 to 5
Average Daily Caloric Adequacy
Average daily caloric adequacy received through enteral nutrition was defined by percentage of goal calories achieved per day (percentage calorie goal achieved=actual calorie achievement/total participant-specific target calories). The values in the 5-day period and the 14-day period were averaged.
Time frame: Days 1 to 5 and Days 1 to 14
Time to Resolution of Enteral Feeding Intolerance (EFI)
Time to resolution of EFI is defined as the time needed to achieve GRV less than or equal to 250 ml in the absence of vomiting/retching.
Time frame: Days 1 to 14 or until resolution of EFI, whichever occurs first
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Percentage of Participants Achieving at Least 80% of Daily Goal Calories
Time frame: Days 1 to 14 or end of treatment
Percentage of Participants Achieving at Least 80% of Daily Goal Protein
Time frame: Days 1 to 14 or end of treatment
Ctrough: Observed Concentration at the End of a Dosing Interval of TAK-954
Time frame: Day 5 pre-dose