Conditions: Cancer
Keywords: cancer related pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: no

Brief summary:
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

Detailed description:
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.

Arms:
arm 1: Trade name is Targin(fixed combination drug). arm 2: Trade name is Oxycontin(single compound).

Interventions: intervention 1: Oxycodone/Naloxone intervention 2: Oxycodone(single compound)
Intervention descriptions: intervention 1: Dose and administration : Upto 40mg B.I.D per daily. intervention 2: Dose and administration : Upto 40mg B.I.D per daily.

Protocol document: