constipation methylnaltrexone opioid obstipatie
Conditions
Interventions
The three study groups (morphine sulphate, oxycodon and fentanyl) will all receive treatment with methylnaltrexone every other day for 14 days (7 doses).
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: . 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 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 /= 3 days before the first dose of methylnaltrexone. This is defined as at least one type of laxative in an adequate dosing regimen, (e.g. macrogol 2 packets daily, magnesium(hydr)oxide 500 mg three times daily, bisacodyl 10 mg daily or sennoside A+B 10 ml daily) or at least two types of laxatives in a suboptimal dose with patient characteristics hampering optimal treatment. 11. If the subject is a woman with presumed child bearing potential; negative urine pregnancy test at screening 12. Surgically sterile or agrees to use a medically acceptable method of birth control or practice sexual abstinence for the duration of the methylnaltrexone treatment and the following 15 days. ~ * including laxation after rescue laxative or enema ~ not necessary for postmenopausal women
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 /= 2 consecutive days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 - changes in immunologic and angiogenic markers | — |
Contacts
Public ContactH.M.W. Verheul
De Boelelaan 1117
Outcome results
None listed