Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03477903
Registration number
NCT03477903
Ethics application status
Date submitted
19/03/2018
Date registered
27/03/2018
Date last updated
24/09/2019
Titles & IDs
Public title
TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
U1111-1208-1831
Query!
Secondary ID [2]
0
0
TAK-954-2002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Critical Illness
0
0
Query!
Enteral Nutrition
0
0
Query!
Enteral Feeding Intolerance
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TAK-954
Treatment: Drugs - Metoclopramide
Treatment: Drugs - Normal Saline
Experimental: Group A: TAK-954 0.1 mg - TAK-954 0.1 milligram (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliter (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
Experimental: Group B: TAK-954 0.3 mg - TAK-954 0.3 mg, intravenously, administered as 60 minute-infusion, once daily along with 2 mL normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
Experimental: Group C: TAK-954 1.0 mg - TAK-954 1.0 mg, intravenously, administered as 60 minute-infusion, once daily along with 2 mL normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.
Active Comparator: Group D: Metoclopramide 10 mg - Metoclopramide 10 mg, injection, intravenously, three times a day along with 100 mL normal saline 60-minute infusion, intravenously, once daily for a minimum of 5 days up to a maximum of 14 days.
Treatment: Drugs: TAK-954
TAK-954 infusion
Treatment: Drugs: Metoclopramide
Metoclopramide infusion
Treatment: Drugs: Normal Saline
0.9% sodium chloride for injection
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Average Daily Protein Adequacy Over the First 5 Days of Treatment
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Days 1 to 5
Query!
Secondary outcome [1]
0
0
Average Daily Protein Adequacy Over the Study Treatment Period
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Days 1 to 14
Query!
Secondary outcome [2]
0
0
Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Days 1 to 5
Query!
Secondary outcome [3]
0
0
Average Daily Caloric Adequacy
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Days 1 to 5 and Days 1 to 14
Query!
Secondary outcome [4]
0
0
Time to Resolution of Enteral Feeding Intolerance (EFI)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Days 1 to 14 or until resolution of EFI, whichever occurs first
Query!
Secondary outcome [5]
0
0
Percentage of Participants Achieving at Least 80% of Daily Goal Calories
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Days 1 to 14 or end of treatment
Query!
Secondary outcome [6]
0
0
Percentage of Participants Achieving at Least 80% of Daily Goal Protein
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Days 1 to 14 or end of treatment
Query!
Secondary outcome [7]
0
0
Ctrough: Observed Concentration at the End of a Dosing Interval of TAK-954
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Day 5 pre-dose
Query!
Eligibility
Key inclusion criteria
1. Has at least a size 12-(french size) Fr nasogastric or orogastric tube with its tip at
least 10 centimeter (cm) below the esophagogastric junction confirmed radiologically
(the tip of the tube must be in the body or the antrum of the stomach and not in the
fundus).
2. Is intubated and mechanically ventilated in the ICU.
3. Is expected to remain alive, mechanically ventilated, and receive continuous enteral
feeding for >=48 hours following randomization.
4. Have EFI, defined as a single GRV measurement of >=250 mL with vomiting/retching
within the last 24 hours, or a single GRV measurement of >=500 mL with or without
vomiting/retching within the last 24 hours.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Is under consideration for withdrawal of life-sustaining treatments within the next 72
hours.
2. Has had major esophageal or gastric surgery or direct luminal trauma on this admission
(participants with lower abdominal surgery are not excluded unless enteral feeding is
contraindicated).
3. Has mechanical bowel obstruction, short bowel syndrome, or the presence of an active
gastric pacemaker.
4. Have pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score
7 to 9 points) or C (severe; total score 10 to 15 points).
5. Has been admitted primarily for treatment of a drug overdose.
6. Has a presence of a post-pyloric tube in place at Randomization that may be used for
enteral nutrition.
7. Is receiving parenteral nutrition (PN) at Screening.
8. Is in diabetic ketoacidosis or non-ketotic hyperosmolar coma.
9. Has a different nutrient requirement than allowed in feeding protocol.(outside a range
of 1.2 to 2 gram per kilogram per day [g/kg/day] of proteins and up to 1.5 kilocalorie
per milliliter [kcal/mL]).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/08/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
29/08/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Royal North Shore Hospital - St. Leonards
Query!
Recruitment hospital [2]
0
0
Royal Brisbane and Women's Hospital - Brisbane
Query!
Recruitment hospital [3]
0
0
Logan Hospital - Meadowbrook
Query!
Recruitment hospital [4]
0
0
Mater Hospital Brisbane - South Brisbane
Query!
Recruitment hospital [5]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [6]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [7]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [8]
0
0
The Northern Hospital - Epping
Query!
Recruitment hospital [9]
0
0
Frankston Hospital - Frankston
Query!
Recruitment hospital [10]
0
0
The Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2065 - St. Leonards
Query!
Recruitment postcode(s) [2]
0
0
4029 - Brisbane
Query!
Recruitment postcode(s) [3]
0
0
4131 - Meadowbrook
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [6]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [7]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [8]
0
0
3076 - Epping
Query!
Recruitment postcode(s) [9]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [10]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Georgia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Idaho
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kentucky
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Nebraska
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New Jersey
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Oklahoma
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Wisconsin
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
British Columbia
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Ontario
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Quebec
Query!
Country [18]
0
0
United Kingdom
Query!
State/province [18]
0
0
England
Query!
Country [19]
0
0
United Kingdom
Query!
State/province [19]
0
0
Scotland
Query!
Country [20]
0
0
United Kingdom
Query!
State/province [20]
0
0
Wales
Query!
Country [21]
0
0
United Kingdom
Query!
State/province [21]
0
0
Liverpool
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Millennium Pharmaceuticals, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03477903
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Millennium Pharmaceuticals, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03477903
Download to PDF