Trial Outcomes & Findings for TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI) (NCT NCT03477903)
NCT ID: NCT03477903
Last Updated: 2019-09-24
Results Overview
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.
TERMINATED
PHASE2
1 participants
Days 1 to 5
2019-09-24
Participant Flow
One participant took part in the study at an investigative site in the United States from 25-Aug-2018 to 29-Aug-2018.
One participant with a diagnosis of Enteral Feeding Intolerance (EFI) was enrolled and received 0.1 mg of TAK-954. No participants were enrolled in the other 3 planned arms of the study.
Participant milestones
| Measure |
TAK-954 0.1 mg
TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
|
|---|---|
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Overall Study
STARTED
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1
|
|
Overall Study
COMPLETED
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0
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
TAK-954 0.1 mg
TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
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|---|---|
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Overall Study
Study Terminated by Sponsor
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1
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Baseline Characteristics
Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
Baseline characteristics by cohort
| Measure |
TAK-954 0.1 mg
n=1 Participants
TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
|
|---|---|
|
Region of Enrollment
United States
|
1 Participants
n=1 Participants • Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
|
PRIMARY outcome
Timeframe: Days 1 to 5Population: Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 14Population: Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 5Population: Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 5 and Days 1 to 14Population: Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 14 or until resolution of EFI, whichever occurs firstPopulation: Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 14 or end of treatmentPopulation: Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 14 or end of treatmentPopulation: Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 5 pre-dosePopulation: Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
Outcome measures
Outcome data not reported
Adverse Events
TAK-954 0.1 mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER