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Trial registered on ANZCTR
Registration number
ACTRN12611000002987
Ethics application status
Not yet submitted
Date submitted
15/12/2010
Date registered
4/01/2011
Date last updated
4/01/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
An open-label, pilot study to examine the pharmacokinetics, efficacy and safety of Methylnaltrexone Bromide in paediatric patients with opioid-induced constipation who have failed standard aperient treatment.
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Scientific title
An open-label, pilot study to examine the pharmacokinetics, efficacy and safety of Methylnaltrexone Bromide in paediatric patients with opioid-induced constipation who have failed standard aperient treatment.
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Secondary ID [1]
253300
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Nil
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Universal Trial Number (UTN)
U1111-1118-5324
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Opioid-induced Constipation
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Condition category
Condition code
Oral and Gastrointestinal
258969
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A single subcutaneous injection of Methylnaltrexone Bromide (0.15mg/kg) at baseline. If the injection has not been effective within 24 hours (ie no bowel action), the injection may be repeated (but the pharmacokinetic samples will not be repeated).
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Intervention code [1]
257747
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Treatment: Drugs
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Comparator / control treatment
No comparator. Pharmacokinetic study.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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A pharmacokinetic profile of one dose of Methylnaltrexone Bromide in paediatric patients with opioid-induced constipation will be established from PK blood samples collected at 1, 2, 4, 8, 12 and 24 hours after the time of injection. The area under the curve will be calculated.
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Assessment method [1]
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Timepoint [1]
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24 hour pharmacokinetic sampling period
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Secondary outcome [1]
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The effectiveness of Methylnaltrexone Bromide in a paediatric population with opioid induced constipation will be assessed with the use of a bowel action diary. The log features the Bristol Stool Chart to assist with categorising stool type, as well as space for completing day, time, amount, strain, pain, tummy ache and rectal bleeding.
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Assessment method [1]
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Timepoint [1]
268649
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The bowel movement diary will be completed any time there is a bowel movement from the time of injection up to 1 week post injection.
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Secondary outcome [2]
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The safety of Methylnaltrexone Bromide in a paediatric population with opioid induced constipation
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Assessment method [2]
268650
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Timepoint [2]
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Adverse reactions will be monitored and recorded at Time point 0hours, 1, 2, 4, 8, 12, 24 hours post injection and up to 1 week post injection.
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Eligibility
Key inclusion criteria
An inpatient at the Royal Children's Hospital
Diagnosis of constipation as defined by lack of bowel motion for 3 days
Chronic opioid treatment (1 week continuous duration)
Failed all other standard aperient treatment
Vascular access
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Minimum age
No limit
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Other causes of constipation (eg cow's milk protein intolerance, poor oral intake)
Signs and symptoms of bowel obstruction
Suspected or diagnosed with delirium
Likely to pass away this admission
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Suitable subjects will be identified by ward staff and brought to the attention of the PI. The PI will approach the subject (or guardian) and provide them with an Information Statement. If the subject is interested in taking part in the study, they will be screened and if they meet all inclusion critteria and no exclusion criteria, they will be enrolled.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study is an open label, pilot study. All subjects will be provided with the active injection.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Open label, pilot, pharmacokinetic study
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Phase
Phase 4
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
6
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
Hospital
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Name
The Royal Children's Hospital
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Address
50 Flemington Rd, Parkville 3052, Victoria
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
257385
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Address [1]
257385
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Country [1]
257385
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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The Royal Children's Hospital Human Research Ethics Committee
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Ethics committee address [1]
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50 Flemington Rd
Parkville Victoria 3052
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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10/01/2011
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Approval date [1]
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Ethics approval number [1]
260197
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Summary
Brief summary
The use of Methylnaltrexone Bromide is approved to treat adults with opioid-induced constipation, but it has not yet been test in children with opioid-induced constipation. This study will see how safe and effective Methylnaltrexone Bromide is in children with opioid-induced constipation.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Adrian Dabscheck
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Address
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The Royal Children's Hospital
50 Flemington Rd
Parkville VIC 3052
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Country
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Australia
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Phone
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+61 3 9345 6987
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Adrian Dabscheck
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Address
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The Royal Children's Hospital
50 Flemington Rd
Parkville VIC 3052
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Country
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Australia
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Phone
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+61 3 9345 6987
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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