A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients

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

Timeline

Start

2011-05

Primary completion

2013-10

Completion

2014-06

Publications

• Lee KH, Kim TW, Kang JH, Kim JS, Ahn JS, Kim SY, Yun HJ, Eum YJ, Koh SA, Kim MK, Hong YS, Kim JE, Lee GW. Efficacy and safety of controlled-release oxycodone/naloxone versus controlled-release oxycodone in Korean patients with cancer-related pain: a randomized controlled trial. Chin J Cancer. 2017 Sep 11;36(1):74. doi: 10.1186/s40880-017-0241-4.

Drugs

Indications