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Trial record 1 of 1 for:    NCT03477903
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TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)

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ClinicalTrials.gov Identifier: NCT03477903
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

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.

Condition or disease Intervention/treatment Phase
Critical Illness Enteral Nutrition Enteral Feeding Intolerance Drug: TAK-954 Drug: Metoclopramide Phase 2

Detailed Description:

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 25, 2018
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: TAK-954
TAK-954 infusion

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.
Drug: TAK-954
TAK-954 infusion

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.
Drug: TAK-954
TAK-954 infusion

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.
Drug: Metoclopramide
Metoclopramide infusion




Primary Outcome Measures :
  1. Average Daily Protein Adequacy [ Time Frame: Day 1 up to Day 5 ]
    Average daily protein adequacy received through enteral nutrition is defined as the 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.


Secondary Outcome Measures :
  1. Average Daily Protein Adequacy [ Time Frame: Day 1 up to Day 14 ]
    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.

  2. Average Daily Change in 24-hour Gastric Residual Volume (GRV) [ Time Frame: Day 1 up to Day 5 ]
  3. Average Daily Caloric Adequacy [ Time Frame: Day 1 up to Day 5; Day 1 up to Day 14 or treatment completion ]
    Average daily caloric adequacy received through enteral nutrition is defined as percentage of goal calories achieved per day. Percentage of goal calories achieved is calculated as the ratio of actual calorie achievement to the total participant-specific target calories.

  4. Time to Resolution of EFI [ Time Frame: Day 1 up to Day 14 or until resolution of EFI, whichever occurs first ]
    Time to resolution of EFI is defined as the time needed to achieve GRV less than or equal to (<=) 250 milliliter (mL) in the absence of vomiting/retching.

  5. Percentage of Participants with at least 80 Percent (%) Daily Goal Calories [ Time Frame: Day 1 up to Day 14 or treatment completion ]
  6. Percentage of Participants with at least 80% Daily Goal Protein [ Time Frame: Day 1 up to Day 14 or treatment completion ]
  7. Ctrough: Observed Concentration at the end of a Dosing Interval for TAK-954 [ Time Frame: Day 5 post-dose ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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]).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477903


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

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Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Director Millennium Pharmaceuticals, Inc.

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03477903     History of Changes
Other Study ID Numbers: TAK-954-2002
U1111-1208-1831 ( Other Identifier: WHO )
2017-003206-41 ( EudraCT Number )
18/NE/0139 ( Registry Identifier: NRES )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug therapy

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action