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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01953081
Ethics application status
Date submitted
25/09/2013
Date registered
30/09/2013

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
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
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
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01953081