TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)
NCT ID: NCT03477903
Last Updated: 2019-09-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2018-08-25
2018-08-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
TAK-954
TAK-954 infusion
Normal Saline
0.9% sodium chloride for injection
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.
TAK-954
TAK-954 infusion
Normal Saline
0.9% sodium chloride for injection
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.
TAK-954
TAK-954 infusion
Normal Saline
0.9% sodium chloride for injection
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.
Metoclopramide
Metoclopramide infusion
Normal Saline
0.9% sodium chloride for injection
Interventions
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TAK-954
TAK-954 infusion
Metoclopramide
Metoclopramide infusion
Normal Saline
0.9% sodium chloride for injection
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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 \[kcal/mL\]).
18 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Millennium Pharmaceuticals, Inc.
Locations
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Joseph M Still Burn Centers
Augusta, Georgia, United States
Eastern Idaho Medical Consultants
Idaho Falls, Idaho, United States
Illinois Lung & Critical Care Institute
Peoria, Illinois, United States
University of Kentucky Health Care
Lexington, Kentucky, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Truman Medical Center Hospital Hill
Kansas City, Missouri, United States
Creighton University
Omaha, Nebraska, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
New York-Presbyterian Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Froedtert Hospital
Wauwatosa, Wisconsin, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Logan Hospital
Meadowbrook, Queensland, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
The Northern Hospital
Epping, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Royal Columbian Hospital
New Westminster, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Hopital Charles-LeMoyne
Greenfield Park, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Monteal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval
Québec, Quebec, Canada
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, United Kingdom
Royal Sussex County Hospital
Brighton, England, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, England, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, England, United Kingdom
The Royal London Hospital
London, England, United Kingdom
Royal Free London NHS Foundation Trust
London, England, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust
London, England, United Kingdom
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
NHS Lothian
Edinburgh, Scotland, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, United Kingdom
Cardiff and Vale University Health Board
Cardiff, Wales, United Kingdom
Aneurin Bevan University Health Board
Newport, Wales, United Kingdom
Royal Liverpool University Hospital NHS Trust
Liverpool, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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U1111-1208-1831
Identifier Type: OTHER
Identifier Source: secondary_id
2017-003206-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18/NE/0139
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-954-2002
Identifier Type: -
Identifier Source: org_study_id
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