An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders
Condition: Spinal Disorders
MeSH terms: Spinal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Study Objectives:

        1. Primary objective

           - To assess the pain reduction after 8 weeks treatment from baseline (week 0)

        2. Secondary objectives

             -  To assess the pain reduction after 4 weeks treatment from baseline (week 0)

             -  To assess the EQ-5D

             -  To assess physician's overall satisfaction

             -  To assess subject's overall satisfaction

             -  To assess safety
    

Detailed description: 
      Study Design (Methodology):

      This will be a multicenter, phase IV, interventional study to assess the efficacy and safety
      of TARGIN(R)(Oxycodone/Naloxone) in Korean patients who are dissatisfied with their current
      analgesic medication (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, EQ-5D, physician's overall
      satisfaction and subject's overall satisfaction. If patient is eligible in
      inclusion/exclusion criteria at the time of visit 1, the patient will receive treatment with
      TARGIN(R). Re-screening, study drug dose interruption is not allowed. The duration of study
      drug dose interruption is defined as for 1 week.

      Treatment with TARGIN(R) will be started at 5/2.5mg b.i.d.,and proper titration (up
      titration) will be allowed at each visit or at unscheduled visit according to the
      investigator's decision. On-site visit or phone call will be allowed for visit 2(wk 1).The up
      titration will be considered by investigator's judgement as followings; (1) if the rescue
      medication was used more than 2 times per day, on average or (2) based on the daily average
      numerical rating scale

      , if the numerical rating scale was changed to worsen since the previous visit, (3)
      Investigator's judgement by considering any titration needed situation (e.g. dose, frequency
      of rescue medication). Pain assessment by investigator at each visit will be used for
      analysis and criteria for uptitration. Daily pain diary will be used for only criteria for
      uptitration.

      Safety laboratories will be obtained at baseline (visit 1) and study end (visit 4) in a local
      laboratory. The laboratory values within 4 weeks prior to baseline (visit 1) will be allowed
      to use at study visit 1.

      The rescue medication is the IRcodon(R).

      Patients will be withdrawn from the study if the following circumstance require study drug
      discontinuation:

        -  Failure of pain control (Failure of pain control will be decided by investigators
           judgement, e.g. there is poor pain control or lack of efficacy despite 2~3 times of
           titration.)

        -  Adjustment of the other analgesics due to Adverse event except TARGIN(R) or IRcodon(R)

        -  Adjustment of the other major pain management modality (e.g. surgery, non-surgical
           interventional therapy, etc.)

        -  Withdrawal of informed consent

        -  Pregnancy

        -  Any other significant risk to the patient's safety in the clinical judgement of the
           investigator
    

Intervention name(s): Oxycodone/naloxone
Intervention type(s): Drug
Intervention description(s): Targin 5mg, 10mg, 20mg up to 40mg b.i.d
Other intervention name(s): Targin
Intervention MeSH terms: Oxycodone; Naloxone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: spinal disorders