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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01039805




Registration number
NCT01039805
Ethics application status
Date submitted
23/12/2009
Date registered
25/12/2009

Titles & IDs
Public title
Evaluation of Single Doses of GSK962040 in Critically Ill Patients With Enteral Feed Intolerance
Scientific title
A Double-blind, Randomized, Placebo Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Critically Ill Male and Female Patients With Enteral Feed Intolerance
Secondary ID [1] 0 0
112571
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK962040 (50 mg)
Treatment: Drugs - Placebo
Treatment: Drugs - GSK962040 (75 mg)

Experimental: Cohort 1 - Subjects randomized to either GSK962040 (50 mg) or placebo

Experimental: Cohort 2 - Subjects randomized to either GSK962040 (75 mg) or placebo


Treatment: Drugs: GSK962040 (50 mg)
Cohort 1 = 50 mg

Treatment: Drugs: Placebo
matching placebo

Treatment: Drugs: GSK962040 (75 mg)
Cohort 2 = 75 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gastric emptying
Timepoint [1] 0 0
3 days
Primary outcome [2] 0 0
Safety and tolerability of GSK962040
Timepoint [2] 0 0
5 days
Primary outcome [3] 0 0
Pharmacokinetic parameters of GSK962040: Cmax, Tmax, AUC(0-inf), AUC(0-t), CL/F, V/F, and half-life
Timepoint [3] 0 0
3 days
Secondary outcome [1] 0 0
Pre and post GSK962040 dose Gastric Residual Volume (GRV)
Timepoint [1] 0 0
Duration of dosing
Secondary outcome [2] 0 0
Pharmacokinetic parameters of paracetamol
Timepoint [2] 0 0
duration of dosing
Secondary outcome [3] 0 0
Pharmacokinetic parameters of 3OMG
Timepoint [3] 0 0
duration of dosing
Secondary outcome [4] 0 0
Plasma concentrations of motilin
Timepoint [4] 0 0
duration of dosing

Eligibility
Key inclusion criteria
* Male or female between 18-85 years of age, at the time consent is obtained.
* Mechanically ventilated on the Intensive Care Unit who has become intolerant of nasogastric enteral feeding.
* intolerance of nasogastric tube feeding is defined as a gastric aspirate volume (GRV) >250 mL at least 6 hours after commencing feeding at >40 mL/hr.
* Expected to remain mechanically ventilated for at least 48 hours after enrollment and expected to survive for at least 24 hours post dose of study medication.
* Subject has a nasogastric tube for enteral feeding.
* Body weight > or = 50 kg
* Written informed consent may be obtained from a legally acceptable representative, which includes compliance with the requirements and restrictions listed in the consent form. In most cases, consent will be sought from next of kin as the subject will not be competent to give their own consent.
* Average QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
* AST and ALT < 3xULN; alkaline phosphatase and bilirubin < or = 2xULN.
* Subjects who have rapidly rising aminotransferases or for whem there is not a plausible explanation for the observed elevation will not be enrolled
* LFTs will be checked for eligibility on screening and again prior to dosing with GSK962040.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects that have received a gastric prokinetic agent in the previous 24 h (e.g., erythromycin, azithromycin, metoclopramide). These agents are prohibited for the duration of the study.
* Subjects whose clinical condition is deteriorating rapidly or any subject for whom the investigator does not consider there is a reasonable expectation that they will be able to complete the study.
* Subjects who are known to be infected with Hepatitis B, Hepatitis C, or HIV viruses.
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to dosing of study medication.
* Subjects with renal failure requiring replacement therapy (dialysis or filtration).
* Subjects for whom the reason for admission to ICU was an overdose (deliberate or accidental; medicinal product or not).
* Subjects with altered upper gastrointestinal tract anatomy and subjects who have undergone upper gastrointestinal tract surgery on this admission to ICU.
* Subjects with bowel obstruction or perforation.
* Subject has a gastric pacemaker
* Subject is receiving parenteral feeding
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
* Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
* Lactating females.

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 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
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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 not provided in https://clinicaltrials.gov/study/NCT01039805