Evaluation of the efficacy and safety of add-on therapy with the synthetic cannabinomimetic nabilone in patients with tumor pain

INTERVENTION: Product Name: Nabilone 0,5 mg Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Pain related to cancer (solid tumors) PRIMARY OUTCOME: Main Objective: Safety and efficacy of Nabilone in patients with cancer pain (VAS) Primary end point(s): Intensity of pain (VAS) Secondary Objective: Impact of Nabilone on quality of life, sleep, appetite and concomitant medication 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