Pain related to cancer (solid tumors)
Conditions
Interventions
Product Name: Nabilone 0,5 mg
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
ZISOP Zentrum für interdisziplinäre Schmerztherapie Landeskrankenhaus Klagenfurt
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -patients with solid tumors and associated pain unresponsive to stable doses of opioids or intolerance of opioids - willingness to use basic pain medicine at stable dose durung the trial - age above 18 years - written informed consent 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: - schizophrenia, psychosis, severe psychiatric illenes in the anamnesis - known drug abuse - pregnancy and breastfeeding - pretherapy with cannabinoids (4 weeks before inclusion) - planned change of chemotherapy related to the underlying disease during study period (including radiation) - myocardial infarction or clinically relevant cardiac dysfunction (12 months before inclusion) - Lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and efficacy of Nabilone in patients with cancer pain (VAS);Secondary Objective: Impact of Nabilone on quality of life, sleep, appetite and concomitant medication;Primary end point(s): Intensity of pain (VAS) | — |
Countries
Austria
Outcome results
None listed