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

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

NCT01953081

0082

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