A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Condition: Cancer
MeSH terms: Peripheral Nervous System Diseases
Intervention: Targin
Intervention description: Single arm for Targin
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: 73.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Targin; Chemotherapy Induced Peripheral Neuropathy (CIPN)

Summary:

      A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin
      (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy)
      who need opioid combination treatment with existing pregabalin of last dose prior to study
      enrollment without changing.

      The investigators will assess study objectives as below.

      Primary objective

        -  To assess the pain reduction rate after 4 weeks treatment from baseline (week 0)

      Secondary objectives

        -  To assess the Functional Assessment of Cancer Therapy/Gynecologic Oncology
           Group-Neurotoxicity (FACIT-GOG/NTX)

        -  To assess physician's overall satisfaction

        -  To assess subject's overall satisfaction

        -  To assess safety

      The investigators have a hypothesis that Targin will show favorable efficacy & safety profile
      for CIPN patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 20 and <80 years of age

          -  Patients who has diagnosed as Chemotherapy-Induced Peripheral Neuropathy by
             investigator's judgment

          -  Patient who are receiving pregabalin for the treatment of Chemotherapy- Induced
             Peripheral Neuropathy

          -  Patients who have moderate to severe pain intensity which is not controlled with 300mg
             of pregabalin per day for at least 1 week: NRS ≥ 4

          -  Patients who need opioid combination treatment with existing pregabalin treatment

          -  Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90
             days)

          -  Patients who signed a written informed consent form

        Exclusion Criteria:

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant. UNLESS they are:

               -  women whose 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 spermicidal. Hormonal contraceptives include any marketed
                  contraceptive agent that includes an estrogen and/or (Progest - progesterone)
                  progestational agent.

          -  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 or Naloxone or to any of the
             excipients

          -  Patients with severe respiratory depression with hypoxia and/or hypercapnia

          -  Patients with severe chronic obstructive pulmonary disease

          -  Patients with cor pulmonale

          -  Patients with severe bronchial asthma

          -  Patients with non-opioid induced paralytic ileus

          -  Patients with moderate to severe hepatic impairment

          -  Targin 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 neural blockade procedure or
             regional infusion

          -  Patients with increased intracranial pressure

          -  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

          -  Patients with myxoedema, not adequately treated hypothyroidism or Addison's 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

          -  Chemotherapy or radiotherapy within 2 weeks prior to the screening visit, or planned
             chemotherapy or radiotherapy during the study period.

          -  Mainly pain originated other than Chemotherapy-Induced Peripheral Neuropathy

          -  Patients with diabetic neuropathy

          -  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

          -  Having used other investigational drugs at the time of enrollment, or within 30 days
             of enrollment