Not Yet RecruitingPhase 4ACTRN12611000002987

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.


Sponsor

The Royal Children's Hospital

Enrollment

6 participants

Start Date

Apr 1, 2011

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a medication called methylnaltrexone bromide in children who are constipated due to opioid pain medications and haven't responded to standard treatments. Researchers want to understand how the drug works in young patients' bodies and whether it safely helps relieve constipation caused by long-term opioid use.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 t

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).


Locations(1)

Australia

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ACTRN12611000002987


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