patients receiving palliative care suffering from opioid induced constipation MedDRA version: 14.1 Level: PT Classification code 10059513 Term: Palliative care System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Relistor
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methylnaltrexone bromide
CAS Number: 73232-52-7
Other descriptive name: METHYLNALTREXONE BROMIDE
Concentration uni
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 95
Exclusion criteria
Exclusion criteria: 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. 11. Known or suspected allergy to methylnaltrexone or similar compounds (e.g. naltrexone or naloxone) 12. Participation in a study with investigational products within 30 days before first dose of methylnaltrexone. 13. Pregnant or nursing 14. Clinically important abnormalities that may interfere with participation or compliance to the study, determined by investigator Additional exclusion criteria for the immunologic and angiogenic analysis part of the study: 15. Chemotherapy or treatment with tyrosine kinase inhibitor during 4 weeks before inclusion or treatment scheduled during participation in this study. 16. Treatment with high dose corticosteroids during 2 weeks before inclusion in this study. This is defined as the equivalent of 30 mg of prednisone per day for = 2 consecutive days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of a fixed dose of subcutaneous methylnaltrexone to induce laxation in patients receiving palliative care who suffer from constipation due to either fentanyl, oxycodone or morphine sulphate (opioids with different mechanisms of action).;Secondary Objective: 1) To determine size, phenotype, and function of various leukocyte subsets as well as serum cytokine levels during treatment with the µ-opioid receptor antagonist methylnaltrexone. 2) To determine whether systemic antagonistic treatment with methylnaltrexone will modify systemic biomarkers of angiogenesis. ;Primary end point(s): The proportion of subjects that has a rescue-free laxation response within 4 hours after at least 2 of the first 4 doses (the first week of treatment). ;Timepoint(s) of evaluation of this end point: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to first laxation - Laxation within 4 hours after the first dose of study drug - Laxation within 4 or 24 hours after each dose - Laxation within 4 hours after at least 4 of the maximum 7 doses - Number of laxations per week - Change in BFI score between day 0 and 14 ;Timepoint(s) of evaluation of this end point: Day 14 | — |
Countries
Netherlands
Contacts
Public ContactHenk M.W. Verheul
VU University Medical Center
Outcome results
None listed