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A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance

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Takeda

Status and phase

Completed
Phase 2
Phase 1

Conditions

Enteral Feeding Intolerance

Treatments

Drug: TD-8954
Drug: Metoclopramide

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This study is being conducted to evaluate the safety, tolerability and early efficacy of IV TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are admitted to the intensive care require mechanical ventilation, and are intolerant to enteral feeding.

Enrollment

13 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study
  • Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV measurement ≥250 mL within the 24 hours before randomization

Exclusion criteria

  • History of diabetic or idiopathic gastroparesis
  • Screening blood glucose >15 mmol/L (270 mg/dL) while receiving insulin
  • Impaired renal function, as defined by estimated glomerular filtration rate (eGFR) <30 mL/min, as determined by the Cockcroft-Gault formula -Bilirubin concentration in blood >2 times the upper limit of normal
  • ALT or AST >3 times upper limit of normal
  • Alkaline phosphatase >2 times upper limit of normal
  • Contraindication to enteral feeding
  • Opioid or other drug overdose as the primary reason for admission to Intensive Care Unit (ICU)
  • Receipt of a drug that can be used as a gastric prokinetic agent
  • Receipt of agents known to directly influence the 5 HT4/acetylcholine prokinetic mechanism

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

13 participants in 2 patient groups

TD-8954
Experimental group
Description:
TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
Treatment:
Drug: TD-8954
Metoclopramide
Active Comparator group
Description:
Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
Treatment:
Drug: Metoclopramide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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