Clinical evaluation of the efficacy of methylnaltrexone in resolving constipation induced by different opioid subtypes combined with laboratory analysis of immunomodulatory and antiangiogenic effects of methylnaltrexone

VU University Medical Center0 sitesMay 29, 2012

Overview

No summary available.

Registry

who.int

Start Date

May 29, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

VU University Medical Center

•1\. Age \= 18 years
•2\. Receiving palliative care
•3\. Life expectancy \= 2 weeks
•4\. Able to give informed consent
•5\. Receiving opioid treatment with either morphine sulphate, oxycodone or fentanyl
•6\. Opioid treatment, both
•o On a regular schedule (not just as needed or rescue doses) for the control of pain or dyspnea for at least 2 weeks before the first dose of methylnaltrexone, and
•o On a stable opioid regimen for at least 3 days before the first dose of methylnaltrexone. This is defined as no dose reduction of \= 50%, dose increases are permitted. If rescue medication is prescribed of a different type of opioid than the regular dosed opioid, the rescue medication should be switched to the same type as the regular dosed opioid for at least 3 days before the first dose of methylnaltrexone.
•7\. Has diagnosis of constipation, defined as either
•o \< 3 bowel movements during the previous week by history and no clinically notable laxation\* in the 24 hours before the first dose of methylnaltrexone, or

•1\. Previous treatment with methylnaltrexone
•2\. Known or suspected mechanical gastrointestinal obstruction
•3\. Presence of an other cause of bowel dysfunction that is considered to be a major contribution to the constipation according to investigator
•4\. Presence of a peritoneal catheter for intraperitoneal chemotherapy or dialysis
•5\. Clinically relevant active diverticular disease
•6\. History of bowel surgery within 10 days before first dose of methylnaltrexone
•7\. Fecal ostomy
•8\. Use of vinca alkaloids within previous 4 months
•9\. Body weight \<38 kg
•10\. Renal failure defined as EGFR \<30 ml/min per 1\.73m2 or requires dialysis.