This study is to evaluate the efficacy and safety of a titration method by selects 10 mg control-released (CR) oxycodone tablet as background drug in combined with immediate-released (IR) oxycodone, compared to conventional titration method with immediate-released (IR) oxycodone in patients with moderate to severe cancer pain in Taiwan.
Name: Oxycodone
Name: Oxycodone
Description: The change from baseline of NRS pain score and the daily number of breakthrough pain
Measure: To evaluate the variable change of NRS pain score and the number of breakthrough pain to obtain pain control after treatment Time: Up to 14 daysDescription: The percentage of patients in each titration cycle
Measure: To evaluate the percentage of patients in each titration cycle Time: Up to 14 daysDescription: The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Measure: To evaluate the number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control Time: Up to 14 daysDescription: The total opioid taken within 24 hrs daily from baseline to day 14
Measure: The total opioid taken within 24hrs daily from baseline to day 14 Time: Up to 14 daysDescription: Mean daily NRS score of patients from baseline to day 14
Measure: To evaluate the mean daily NRS score of subjects from baseline to day 14 Time: Up to 14 daysDescription: The total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14
Measure: To evaluate the total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14 Time: Up to 14 daysDescription: The occurrence rate of adverse events and physical examination status
Measure: To evaluate the tolerability and safety of Oxycodone CR and IR in cancer pain patient Time: Up to 28 daysDescription: The change from baseline in questionnaire
Measure: To evaluate the change from baseline in questionnaire Time: Up to 14 daysAllocation: Randomized
Parallel Assignment
There is one SNP
Meanwhile, the titration with IR oxycodone will be added according to the pain intensity, e.g. if patient receiving 6 tablets of 10 mg CR oxycodone (giving in Q12H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for managing acute pain (rescue use) for the first cycle. --- Q12H ---