Nociceptive cancer pain for which strong opioids are needed MedDRA version: 9.1 Level: LLT Classification code 10058019 Term: Cancer pain
Conditions
Interventions
Product Name: morphine
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: morphine sulphate
CAS Number: 64313
Other descriptive name: MORPHINE SULFATE
Concentration unit: g gram(s)
Con
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - moderate-severe nociceptive cancer pain - clinical treatment with strong opioids - informed consent - in case of cognitive impairment at admission, informed consent of the patient's legal representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the pharmacokinetics and the pharmacogenetics of opioids in relation to effects (+/- achievement of analgesia) and/or the occurrence of dose-limiting side effects in cancer patients treated with strong opioids. ;Secondary Objective: - To study the underlying demographic, clinical and pharmacogenetic factors contributing to the failure of achieving analgesia and/or the occurrence of dose-limiting side effects in individual cancer patients for the opioids morphine, oxycodon, fentanyl and hydromorphon; - To study if the demographic, clinical and pharmacogetic factors contributing to the failure of specific opioids with respect to the achievement of analgesia and/ the occurrence of side effects determine the effect of rotation to another opioid in individual patients; - To delelop a strategy for opioid rotation with respect to the type of the opioid rotated to and its dose in case of failure on primary treatment with a specific opioid in an individual patient. ;Primary end point(s): - achievement of pain control - no dose-limiting side effects | — |
Countries
Netherlands
Outcome results
None listed