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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.
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.
Secondary ID [1] 253300 0
Nil
Universal Trial Number (UTN)
U1111-1118-5324
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid-induced Constipation 258827 0
Condition category
Condition code
Oral and Gastrointestinal 258969 258969 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 257747 0
Treatment: Drugs
Comparator / control treatment
No comparator. Pharmacokinetic study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259824 0
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.
Timepoint [1] 259824 0
24 hour pharmacokinetic sampling period
Secondary outcome [1] 268649 0
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.
Timepoint [1] 268649 0
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.
Secondary outcome [2] 268650 0
The safety of Methylnaltrexone Bromide in a paediatric population with opioid induced constipation
Timepoint [2] 268650 0
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.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Open label, pilot, pharmacokinetic study
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258214 0
Self funded/Unfunded
Name [1] 258214 0
Country [1] 258214 0
Primary sponsor type
Hospital
Name
The Royal Children's Hospital
Address
50 Flemington Rd, Parkville 3052, Victoria
Country
Australia
Secondary sponsor category [1] 257385 0
None
Name [1] 257385 0
Address [1] 257385 0
Country [1] 257385 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260197 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 260197 0
50 Flemington Rd
Parkville Victoria 3052
Ethics committee country [1] 260197 0
Australia
Date submitted for ethics approval [1] 260197 0
10/01/2011
Approval date [1] 260197 0
Ethics approval number [1] 260197 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32017 0
Address 32017 0
Country 32017 0
Phone 32017 0
Fax 32017 0
Email 32017 0
Contact person for public queries
Name 15264 0
Dr Adrian Dabscheck
Address 15264 0
The Royal Children's Hospital
50 Flemington Rd
Parkville VIC 3052
Country 15264 0
Australia
Phone 15264 0
+61 3 9345 6987
Fax 15264 0
Email 15264 0
[email protected]
Contact person for scientific queries
Name 6192 0
Dr Adrian Dabscheck
Address 6192 0
The Royal Children's Hospital
50 Flemington Rd
Parkville VIC 3052
Country 6192 0
Australia
Phone 6192 0
+61 3 9345 6987
Fax 6192 0
Email 6192 0
[email protected]

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.