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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01953081




Registration number
NCT01953081
Ethics application status
Date submitted
25/09/2013
Date registered
30/09/2013
Date last updated
18/02/2020

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
0082
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Enteral Feeding Intolerance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TD-8954
Treatment: Drugs - Metoclopramide

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

Active Comparator: Metoclopramide - Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline


Treatment: Drugs: TD-8954


Treatment: Drugs: Metoclopramide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
6 Days
Primary outcome [2] 0 0
Gastric Retention by Scintigraphy
Timepoint [2] 0 0
180 minutes
Secondary outcome [1] 0 0
Tmax
Timepoint [1] 0 0
72 hours
Secondary outcome [2] 0 0
AUC
Timepoint [2] 0 0
72 hours
Secondary outcome [3] 0 0
Cmax
Timepoint [3] 0 0
72 hours
Secondary outcome [4] 0 0
Gastric Emptying by Breath Test
Timepoint [4] 0 0
180 minutes
Secondary outcome [5] 0 0
Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose
Timepoint [5] 0 0
60 minutes
Secondary outcome [6] 0 0
Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose
Timepoint [6] 0 0
120 minutes
Secondary outcome [7] 0 0
Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose
Timepoint [7] 0 0
240 minutes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Theravance Biopharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01953081
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Canafax, PharmD, FCCP
Address 0 0
Theravance Biopharma, US, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries