NCT01719757

PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain

A 4-week, Open Label, Multi-center, Prospective, Single-arm, Non-interventional Phase IV Study to Evaluate the Efficacy of Targin for the Treatment of Korean Patients With Cancer Pain Under Conditions of Daily Practice

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 359 (actual)
• Sponsor: Mundipharma Korea Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under conditions of daily practice.

Detailed description

An open-label, multi-center, nonrandomized, prospective, non-interventional, observational phase IV trial. At the first visit, a detailed medical history is taken, including previous analgesics and concomitant treatment. After inclusion, patients enter a 4-week observation period during which they will receive bid of TARGIN 10/5mg and/or 20/10mg. The dose adjustments of TARGIN as well as of analgesic co-medication, rescue-medication and other treatments (e.g. laxatives) can be performed at any time-point during the observation period by the physician in dependence of medical demand. The asymmetric dose is allowed during the observation period by the physician's judgment. (e.g. 10/5 mg in the morning and 20/10 mg in the evening). Data are gathered using interview-administered questionnaires at baseline (visit 1) and study end (visit 2). During the observation period, unscheduled visits are allowed after the first visit due to inadequate pain control or occurrence of adverse events.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Oxycodone/Naloxone	Twice daily

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-10-01
• Completion: 2014-04-01
• First posted: 2012-11-01
• Last updated: 2016-08-19
• Results posted: 2016-08-19

Locations

1 site across 1 country: South Korea