PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain
Condition: Cancer
MeSH terms: Cancer Pain
Intervention: Oxycodone/Naloxone
Intervention description: Twice daily
Intervention MeSH terms: Oxycodone; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 359.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Targin, Cancer Pain

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female cancer patients 20 years of age or older

          2. Cancer related pain that requires treatment with continuous around-the-clock strong
             opioid analgesic

          3. Moderate to severe pain intensity (NRS pain score >=4)

          4. Opioid naïve patients or patients not treated with strong opioids (Only except
             occasional PRN) within 13 months or patients who has been on weak opioids

          5. Ability to communicate effectively with the study personnel regarding pain intensity,
             constipation assessment, final assessment of overall efficacy and tolerability

          6. Subject who provide signed and dated written voluntary informed consent

        Exclusion Criteria:

          1. Pregnant or nursing (lactating) women

          2. Have previously received treatment with Targin

          3. Patient with evidence of significant structural/functional abnormalities of GI tract
             which is not appropriate for oral medicine administration

          4. Any history of hypersensitivity to Oxycodone and Naloxone or any excipients

          5. Patients with significant respiratory depression

          6. Patients with acute or severe bronchial asthma or hypercarbia

          7. Any patient who has or is suspected of having paralytic ileus

          8. Severe Chronic obstructive pulmonary disease, pulmonary heart disease

          9. Targin product contains lactose. Patients with rare hereditary problems of galactose
             intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not
             take

         10. Patients with moderate and severe hepatic impairment

         11. 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)

         12. Any situation where opioids are contraindicated

         13. With a life expectancy < 1 month

         14. Any situation where opioids are contraindicated

         15. Mainly pain originated other than cancer or cancer related conditions (eg.
             Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy)

         16. Patients with known or suspected unstable brain metastases or spinal cord compression
             that may require changes in steroid treatment throughout the duration of the study

         17. Patients with uncontrolled seizures

         18. Requiring interventional treatment for pain such as neurodestructive procedure or
             regional infusion

         19. With a history of alcohol abuse within 6 months of screening

         20. With a history of illicit drug abuse within 6 months of screening

         21. Patients with increased intracranial pressure

         22. Having used other investigational drugs at the time of enrollment, or within 30 days.