Clinical 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Enteral Feeding Intolerance
Keywords: Enteral feeding
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2013-09-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 6 Days
measure: Gastric Retention by Scintigraphy
timeFrame: 180 minutes
Secondary outcomes:
measure: Tmax
timeFrame: 72 hours
measure: AUC
timeFrame: 72 hours
measure: Cmax
timeFrame: 72 hours
measure: Gastric Emptying by Breath Test
timeFrame: 180 minutes
measure: Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose
timeFrame: 60 minutes
measure: Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose
timeFrame: 120 minutes
measure: Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: Theravance Biopharma, US, Inc.
name: Daniel Canafax, PharmD, FCCP
role: STUDY_DIRECTOR
References:
citation: Chapman MJ, Jones KL, Almansa C, Barnes CN, Nguyen D, Deane AM. Blinded, Double-Dummy, Parallel-Group, Phase 2a Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Highly Selective 5-Hydroxytryptamine Type 4 Receptor Agonist in Critically Ill Patients With Enteral Feeding Intolerance. JPEN J Parenter Enteral Nutr. 2021 Jan;45(1):115-124. doi: 10.1002/jpen.1732. Epub 2020 Jan 28.