Methods: Patients with bone metastasis-related pain at
Numeric Rating Scale ‡4 were enrolled to this randomized
placebo-controlled trial. They had also received morphine or
transdermal fentanyl patches for at least 1 week. During the
3-day efficacy phase, patients received placebo or 1–3 tablets
of oxycodone/paracetamol (5/325 mg), four times daily for
3 days. All patients kept a daily pain diary. The primary
endpoint was the Pain Intensity Difference (PID). Secondary
endpoints were cases of breakthrough pain and rescue morphine
consumption. Additional analyses included the Short
Form-6 Dimensions (SF-6D) quality-of-life scale and a general
impression (GI) of patient satisfaction with treatment at the
end of the phase.