A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients
Condition: Cancer
Intervention: Oxycodone/Naloxone; Oxycodone(single compound)
Intervention description: Dose and administration : Upto 40mg B.I.D per daily.; Dose and administration : Upto 40mg B.I.D per daily.
Intervention MeSH terms: Oxycodone; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: cancer related pain

Summary:

      Objectives:

      To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity

        1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours
           obtained each evening) within 4 weeks

        2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and
           frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need
           of laxative use and Adverse events
    

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(except PRN) within 4
             weeks or patients who has been on weak opioids

          5. Subject who provide signed and dated written voluntary informed consent

        Exclusion Criteria:

          1. Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant. UNLESS they are:

               -  women whose career, lifestyle, or sexual orientation precludes intercourse with a
                  male partner

               -  women shoes partners have been sterilized by vasectomy or other means

               -  two birth control methods. The two methods can be a double barrier method or a
                  barrier method plus a hormonal method. Adequate barrier methods of contraception
                  include: diaphragm, condom (by the partner), intrauterine device (copper or
                  hormonal), sponge or spermicide. Hormonal contraceptives include any marketed
                  contraceptive agent that includes an estrogen and/or a progestational agent.

          2. 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.

          3. Have previously received treatment with Targin or Oxycontin within 4weeks(28days) of
             screening periods(including PRN)

          4. If subjects started first cycle of chemotherapy during the 2 weeks before the
             screening visit or during the study, they should be excluded from the study.

             And If the chemotherapy regimen or dosage to be planned to change during the study,
             the subjects should be excluded from the study.

          5. Patient who is administered laxatives with stable dose for more than 1 week

          6. Patient with evidence of significant structural/functional abnormalities of GI tract
             which is not appropriate for oral medicine administration. Any history of
             hypersensitivity to Oxycodone and Naloxone

          7. Patients with significant respiratory depression

          8. Patients with acute or severe bronchial asthma or hypercarbia

          9. Any patient who has or is suspected of having paralytic ileus

         10. Severe Chronic obstructive pulmonary disease, pulmonary heart disease

         11. Targin product contains lactose. Patients with rare hereditary problems of galactose
             intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not
             take

         12. Patients with moderate and severe hepatic impairment

         13. 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)

         14. Any situation where opioids are contraindicated

         15. Major surgery within 1 month prior to screening or planned surgery

         16. Mainly pain originated other than cancer or cancer related conditions (eg.
             Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy)

         17. 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

         18. Patients with uncontrolled seizures

         19. Requiring interventional treatment for pain such as neurodestructive procedure or
             regional infusion

         20. With a history of alcohol abuse within 6 months of screening

         21. With a history of illicit drug abuse within 6 months of screening

         22. Patients with increased intracranial pressure

         23. In the investigator's opinion, subjects who are receiving hypnotics or other central
             nervous system (CNS) depressants that may pose a risk of additional CNS depression
             with opioid study medication

         24. Patients with myxoedema, not adequately treated hypothyroidism or Addison's disease

         25. Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or
             buprenorphine)

         26. Patients with evidence of clinically significant gastrointestinal disease (e.g.
             paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the
             gastrointestinal tract (e.g. scarring, obstruction etc) either related or not related
             to the underlying cancer or disease progression

         27. Patients suffering from diarrhea and/or opioid withdrawal

         28. With a disability that may prevent the patient from completing all study requirements
             and in particular, interfere with 24hrs pain intensity score

         29. Clinically significant impairment of cardiovascular, respiratory and renal function

         30. Patient who needs acute dose titration or whose pain intensity fluctuate significantly
             in a short period according to investigator's judgment

         31. Having used other investigational drugs at the time of enrollment, or within 30 days
             or 5 half-lives of enrollment, whichever is longer