An Interventional Study to Assess the Efficacy and Safety of Buprenorphine in Korean Patients With Spinal Disorders

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Korea Ltd
• Treatments: Buprenorphine

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