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
Intervention: Oxycodone/naloxone
Intervention description: Targin 5mg, 10mg, 20mg up to 40mg b.i.d
Intervention MeSH terms: Oxycodone; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: spinal disorders

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 20 and <80 years of age

          -  Patients who have spinal disorders related pain for over 90days

          -  Patients who have moderate to severe pain intensity which is not controlled with weak
             opioids or NSAIDs: NRS ≥ 4

          -  Naïve patients for Oxycodone/Naloxone

          -  Naïve patients for strong opioid

          -  Patients who signed a written informed consent form

        Exclusion Criteria:

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive urine pregnancy test

          -  Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients

          -  Patients with severe respiratory depression with hypoxia and/or hypercapnoea

          -  Patients with severe chronic obstructive pulmonary disease

          -  Patients with cor pulmonale

          -  Patients with severe bronchial asthma

          -  Patients who have been diagnosed or is suspected of having paralytic or obstructive
             ileus.Patients with moderate to severe hepatic impairment

          -  Targin(R) product contains lactose. Patients with rare hereditary problems of
             galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
             should not take

          -  Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT),
             or alkaline phosphatase levels (>2.5 times the upper limit of normal, it is allowed >5
             times the upper limit of normal in case of transition in liver) or an abnormal total
             bilirubin and/or creatinine level (s)(greater than 1.5 times the upper limit of
             normal), gamma glutamyl transpeptidase (GGT or GGTP) ≥ 3 times the upper limit of
             normal

          -  Patients with uncontrolled seizures

          -  Requiring interventional treatment for pain such as neurodestructive procedure or
             regional infusion

          -  Patients with increased intracranial pressure

          -  In the investigator's opinion, subjects who are receiving hypnotics or central nervous
             system (CNS) depressants that may pose a risk of additional CNS depression with opioid
             study medication

          -  Patients with myxodema, not adequately treated hypothyroidism or Addisons disease

          -  Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or
             buprenorphine)

          -  Clinically significant impairment of cardiovascular, respiratory and renal function

          -  Major surgery within 1 month prior to screening or planned surgery

          -  Mainly pain originated other than spinal disorders disease

          -  Non-malignant patients or cancer patients who are receiving any oncology treatment
             that could affect the measure of pain control

          -  Patients with uncontrolled constipation regardless of laxative use and/or laxative
             type

          -  With a disability that may prevent the patient from completing all study requirements
             and in particular, interfere with 24hrs pain intensity score

          -  Patients known to have, or suspected of having a history of drug abuse

          -  Patients with history of opioid or drug dependence

          -  Any situation where opioids are contraindicated

          -  Patient who needs acute dose titration or whose pain intensity fluctuate significantly
             in a short period according to investigator's judgment

          -  Having used other investigational drugs at the time of enrollment

        No additional exclusions may be applied by the investigator, in order to ensure that the
        study population will be representative of all eligible patients.