TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)

September 23, 2019 updated by: Millennium Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Meadowbrook, Queensland, Australia, 4131
        • Logan Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Hospital Brisbane
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Epping, Victoria, Australia, 3076
        • The Northern Hospital
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Canada
      • Quebec, Canada, G1V 4G5
        • Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Royal Columbian Hospital
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hopital Charles-LeMoyne
      • Monteal, Quebec, Canada, H4J 1C5
        • Hopital Du Sacre-Coeur de Montreal
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
  • United Kingdom
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital NHS Trust
    • England
      • Birmingham, England, United Kingdom, B15 2GW
        • University Hospitals Birmingham NHS Foundation Trust
      • Brighton, England, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Bristol, England, United Kingdom, BS2 8HW
        • University Hospitals Bristol NHS Foundation Trust
      • Leeds, England, United Kingdom, LS9 7TF
        • The Leeds Teaching Hospitals Nhs Trust
      • London, England, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, England, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, England, United Kingdom, E1 1BB
        • The Royal London Hospital
      • London, England, United Kingdom, SE1 7EH
        • Guy's and Saint Thomas' NHS Foundation Trust
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4SB
        • NHS Lothian
      • Glasgow, Scotland, United Kingdom, G42 9TY
        • NHS Greater Glasgow and Clyde
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • Cardiff and Vale University Health Board
      • Newport, Wales, United Kingdom, NP20 2UB
        • Aneurin Bevan University Health Board
  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Joseph M Still Burn Centers
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Eastern Idaho Medical Consultants
    • Illinois
      • Peoria, Illinois, United States, 61606
        • Illinois Lung & Critical Care Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Health Care
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center Hospital Hill
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Creighton University
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
    • New York
      • New York, New York, United States, 10032
        • New York-Presbyterian Columbia University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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]).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Normal Saline
0.9% sodium chloride for injection
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
Drug: Normal Saline
0.9% sodium chloride for injection
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
Drug: Normal Saline
0.9% sodium chloride for injection
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: Normal Saline
0.9% sodium chloride for injection
Drug: Metoclopramide
Metoclopramide infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Daily Protein Adequacy Over the First 5 Days of Treatment
Time Frame: Days 1 to 5
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average Daily Protein Adequacy Over the Study Treatment Period
Time Frame: Days 1 to 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 prescribed. The value for each of the 14 days was averaged.
Days 1 to 14
Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment
Time Frame: Days 1 to 5
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.
Days 1 to 5
Average Daily Caloric Adequacy
Time Frame: Days 1 to 5 and Days 1 to 14
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.
Days 1 to 5 and Days 1 to 14
Time to Resolution of Enteral Feeding Intolerance (EFI)
Time Frame: Days 1 to 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 ml in the absence of vomiting/retching.
Days 1 to 14 or until resolution of EFI, whichever occurs first
Percentage of Participants Achieving at Least 80% of Daily Goal Calories
Time Frame: Days 1 to 14 or end of treatment
Days 1 to 14 or end of treatment
Percentage of Participants Achieving at Least 80% of Daily Goal Protein
Time Frame: Days 1 to 14 or end of treatment
Days 1 to 14 or end of treatment
Ctrough: Observed Concentration at the End of a Dosing Interval of TAK-954
Time Frame: Day 5 pre-dose
Day 5 pre-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Millennium Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-954-2002
  • U1111-1208-1831 (Other Identifier: WHO)
  • 2017-003206-41 (EudraCT Number)
  • 18/NE/0139 (Registry Identifier: NRES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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