drugset / Trial / NCT01953081

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

NCT01953081

Phase 1/2 Completed 13 enrolled Takeda Theravance Biopharma · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-01
Primary completion
2014-09
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metoclopramide Small molecule 10 mg Intravenous
Subject felcisetrag Small molecule 0.5 mg Intravenous