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

Enteral Feeding Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953081
• Other study ID #: 0082
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2020
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Enteral Feeding Intolerance

Intervention

Drug:
• TD-8954

• Metoclopramide

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Takeda	Theravance Biopharma

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	the number of subjects reporting adverse events by treatment group	6 Days
Primary	Gastric Retention by Scintigraphy	Number of subjects with retention less than 13% at 180 minutes after dosing.	180 minutes
Secondary	Tmax	Time to maximal concentration in plasma	72 hours
Secondary	AUC	Area under the plasma concentration time curve from 0 to 72 hours after dosing.	72 hours
Secondary	Cmax	Maximum plasma concentration	72 hours
Secondary	Gastric Emptying by Breath Test	Time to 1/2 gastric emptying by breath test	180 minutes
Secondary	Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose	Mean gastric retention percentage after dosing.	60 minutes
Secondary	Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose	Mean gastric retention percentage after dosing.	120 minutes
Secondary	Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose	Mean gastric retention percentage after dosing.	240 minutes