Conditions: Chronic Pain
Keywords: moderate to severe non-malignant chronic pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 261
Healthy volunteers: no

Brief summary:
Objectives:

1. Objective of main interest

   \- To assess the drop-out rate caused by adverse event\* after 6 weeks treatment
2. Further objectives

   * To assess the drop-out rate caused by adverse event\* after 1 week treatment
   * To assess the pain reduction rate after 6 weeks treatment from baseline
   * To assess the Euroquol (EQ-5D) quality of life
   * To assess physician's overall satisfaction
   * To assess subject's overall satisfaction
   * To assess safety

Detailed description:
Study Design (Methodology):

This will be a single center, open-label, randomised, phase IV, exploratory interventional study to compare the efficacy and tolerability of current titration patterns and slow titration pattern with Targin® (Oxycodone/Naloxone) in the treatment of moderate to severe non-malignant chronic pain patients who are dissatisfied with their current analgesic medication World Health Organisation (WHO) step II analgesics).

Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score. If the patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a 1:1 ratio to allocate in Group A or Group B. Re-screening, study drug dose interruption is not allowed.

Arms:
arm 1: Start oxycodone/naloxone 10/5mg b.i.d. titration-\>20/10mg b.i.d.-\>30/15mg b.i.d-\>40/20mg b.i.d. arm 2: Start oxycodone/naloxone 5/2.5mg b.i.d titration-\> 10/5mg b.i.d.-\>20/10mg b.i.d.-\>30/15mg b.i.d-\>40/20mg b.i.d.

Interventions: intervention 1: Oxycodone/naloxone
Intervention descriptions: intervention 1: Oxycodone/naloxone titration

Protocol document: