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
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
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.
Time Perspective: Prospective
Change in numeric rating scales (NRS)
Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2)
Korea: Food and Drug Administration