An Interventional Study to Assess the Efficacy and Safety of Buprenorphine in Korean Patients With Spinal Disorders
Condition: Spinal Disorder
MeSH terms: Spinal Diseases
Intervention: Buprenorphine
Intervention description: 8weeks treatment with Norspan®(Buprenorphine)
Intervention MeSH terms: Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 245.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of
      NORSPAN® from baseline.

      And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0)
      the EQ-5D, the pain and sleep questionnaire, physician's overall satisfaction subject's
      overall satisfaction, and safety
    

Eligibility criteria:

        Inclusion Criteria:

          -  20 years old or above male or female Korean patients

          -  Patients who have spinal disorders related pain

          -  Patients who had been treated with weak opioids and/or NSAIDs before study
             participation

          -  Patients who have moderate to severe pain intensity

          -  Naïve patients for Buprenorphine (Naïve patient are defined as those who had not been
             treated with Buprenorphine 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

               -  using 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.

          -  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 buprenorphine or to any of the excipients

          -  Patients with severely impaired respiratory function or respiratory depression status

          -  Patients concurrently receiving MAOIs or who have received MAOIs within the previous
             two weeks

          -  Patients with convulsive disorders, head injury, shock, a reduced level of
             consciousness of uncertain origin, intracranial lesions or increased intracranial
             pressure, or in patients with severe hepatic impairment

          -  Patients with biliary tract disorders

          -  Patients known to have, or suspected of having a history of drug abuse

          -  Patients with history of opioid or drug dependence

          -  Patients who are concurrently taking other CNS depressants or muscle relaxants that
             may cause respiratory depression, hypotension, profound sedation or potentially result
             in coma.

          -  Patients who are taking Buprenorphine or strong opioid.

          -  Any situation where Buprenorphine is contraindicated

          -  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

          -  With a disability that may prevent the patient from completing all study requirements
             and in particular, interfere with 24hrs pain intensity score

          -  Clinically significant impairment of cardiovascular, respiratory and renal function

          -  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, or within 30 days
             of enrollment