A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain

Inclusion Criteria - Subjects had to meet all the following criteria to be included in this study: 1. Males and females at least 18 years of age (Females less than one year post-menopausal had to have a negative serum or urine pregnancy test recorded within 72 hours prior to the first dose of study medication, be non-lactating, and willing to use adequate and reliable contraception throughout the study.). 2. Documented history of moderate to severe chronic pain of low back that required around-the-clock opioid therapy. 3. Nonmalignant low back pain adequately managed by an opioid analgesic for at least the past 2 weeks. 4. Subjects who required continuation of daily opioid analgesic treatment and were likely to benefit from chronic opioid therapy for the duration of the study. 5. Subjects willing and able to participate in all aspects of the study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent. Amendment No. 1, dated 28-Sep-2004 prior to FPFV, changed the inclusion criteria to * Bullet 3: Nonmalignant low back pain (for example osteoarthrosis / osteoarthritis of spine, deforming spondylosis, spondylolisthesis, disc herniation / sciatica, spinal stenosis) adequately managed by an opioid analgesic for at least the past 2 weeks. * Bullet 4: Subjects who required continuation of daily opioid analgesic treatment and were likely to benefit from chronic opioid therapy (WHO step III opioid) for the duration of the study. (See Section 9.8.1) Any amendments to the protocol are included in Appendix 16.1.1.1. Exclusion Criteria - Subjects who met any of the following criteria were excluded from this study: 1. Any history of hypersensitivity to oxycodone, naloxone, or related products. 2. Subjects currently taking the equivalent of \< 10 mg or \> 40 mg/d oxycodone (Refer to Appendix 12.2 of the protocol: Drug Conversion Tables.). 3. Subjects diagnosed with cancer, not including basal cell carcinoma. 4. Active alcohol or drug abuse with severity sufficient to place the subjects at risk. 5. Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, Electrocardiogram (ECG) results, and physical examination, that would have placed the subject at risk upon exposure…