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 - Methylnaltrexone for opioid induced constipation

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Observational invasive

Sponsor

•1\. Age \>\= 18 years
•2\. Receiving supportive 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
•a) 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
•b) 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.
•7\. If a subject uses a combination of short\- and long\-acting (including continuous administration) opioids, the short\-acting opioid should preferably be of the same type as the long\-acting opioid. If the subject uses a different type of short\-acting opioid than the long\-acting opioid, the subject is allowed to enter the study if he/she has used this short\-acting opioid \<\= 2 times a day in the past three days.
•8\. Has diagnosis of constipation, defined as either

•1\. Previous treatment with methylnaltrexone while using the same opioid subtype
•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, except for patients who\*s defecation pattern was comparable to patients without a fecal ostomy before start of this constipation episode.
•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.

Not specified