Cancer Clinical Trial
Official title:
A 4-week Multicentre, Randomized, Open Label, Parallel Group, Active Control Phase IV Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone in Comparison With Oxycontin in Korean Patients With Cancer Pain(TOP)
Objectives:
To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity
1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours
obtained each evening) within 4 weeks
2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and
frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need
of laxative use and Adverse events
This will be a 4-week multicentre, randomized, open label, parallel group, active control study to evaluate efficacy and safety of Targin in comparison with Oxycontin in Korean patients with cancer pain who are administered weak opioid or naïve patients including patient not on the long term strong opioid medication within 3 months. ;
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