Study Stopped
Insufficient enrollment; No safety concerns
TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)
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
4 other identifiers
interventional
1
4 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2018
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedStudy Start
First participant enrolled
August 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2018
CompletedResults Posted
Study results publicly available
September 24, 2019
CompletedSeptember 24, 2019
September 1, 2019
4 days
March 19, 2018
August 26, 2019
September 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Days 1 to 5
Secondary Outcomes (7)
Average Daily Protein Adequacy Over the Study Treatment Period
Days 1 to 14
Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment
Days 1 to 5
Average Daily Caloric Adequacy
Days 1 to 5 and Days 1 to 14
Time to Resolution of Enteral Feeding Intolerance (EFI)
Days 1 to 14 or until resolution of EFI, whichever occurs first
Percentage of Participants Achieving at Least 80% of Daily Goal Calories
Days 1 to 14 or end of treatment
- +2 more secondary outcomes
Study Arms (4)
Group A: TAK-954 0.1 mg
EXPERIMENTALTAK-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.
Group B: TAK-954 0.3 mg
EXPERIMENTALTAK-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.
Group C: TAK-954 1.0 mg
EXPERIMENTALTAK-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.
Group D: Metoclopramide 10 mg
ACTIVE COMPARATORMetoclopramide 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.
Interventions
0.9% sodium chloride for injection
Eligibility Criteria
You may qualify if:
- 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).
- Is intubated and mechanically ventilated in the ICU.
- Is expected to remain alive, mechanically ventilated, and receive continuous enteral feeding for \>=48 hours following randomization.
- 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.
You may not qualify if:
- Is under consideration for withdrawal of life-sustaining treatments within the next 72 hours.
- 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).
- Has mechanical bowel obstruction, short bowel syndrome, or the presence of an active gastric pacemaker.
- 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).
- Has been admitted primarily for treatment of a drug overdose.
- Has a presence of a post-pyloric tube in place at Randomization that may be used for enteral nutrition.
- Is receiving parenteral nutrition (PN) at Screening.
- Is in diabetic ketoacidosis or non-ketotic hyperosmolar coma.
- 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 \[kcal/mL\]).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Joseph M Still Burn Centers
Augusta, Georgia, 30909, United States
Eastern Idaho Medical Consultants
Idaho Falls, Idaho, 83404, United States
Illinois Lung & Critical Care Institute
Peoria, Illinois, 61606, United States
University of Kentucky Health Care
Lexington, Kentucky, 40536, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Truman Medical Center Hospital Hill
Kansas City, Missouri, 64108, United States
Creighton University
Omaha, Nebraska, 68124, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
New York-Presbyterian Columbia University Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Froedtert Hospital
Wauwatosa, Wisconsin, 53226, United States
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Logan Hospital
Meadowbrook, Queensland, 4131, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
The Northern Hospital
Epping, Victoria, 3076, Australia
Frankston Hospital
Frankston, Victoria, 3199, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W4, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Hopital Charles-LeMoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Hopital du Sacre-Coeur de Montreal
Monteal, Quebec, H4J 1C5, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval
Québec, Quebec, G1V 4G5, Canada
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, B15 2GW, United Kingdom
Royal Sussex County Hospital
Brighton, England, BN2 5BE, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, England, BS2 8HW, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, England, LS9 7TF, United Kingdom
The Royal London Hospital
London, England, E1 1BB, United Kingdom
Royal Free London NHS Foundation Trust
London, England, NW3 2QG, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust
London, England, SE1 7EH, United Kingdom
King's College Hospital NHS Foundation Trust
London, England, SE5 9RS, United Kingdom
NHS Lothian
Edinburgh, Scotland, EH16 4SB, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, G42 9TY, United Kingdom
Cardiff and Vale University Health Board
Cardiff, Wales, CF14 4XN, United Kingdom
Aneurin Bevan University Health Board
Newport, Wales, NP20 2UB, United Kingdom
Royal Liverpool University Hospital NHS Trust
Liverpool, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Millennium Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2018
First Posted
March 27, 2018
Study Start
August 25, 2018
Primary Completion
August 29, 2018
Study Completion
August 29, 2018
Last Updated
September 24, 2019
Results First Posted
September 24, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.