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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Enteral Feeding Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TD-8954

TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours

Group Type EXPERIMENTAL

TD-8954

Intervention Type DRUG

Metoclopramide

Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline

Group Type ACTIVE_COMPARATOR

Metoclopramide

Intervention Type DRUG

Interventions

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TD-8954

Intervention Type DRUG

Metoclopramide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No