A randomised, crossover study of study drug 038 and controlled-release oxycodone HCl tablets in patients with chronic non-cancer pain

INTERVENTION: Oral opioid analgesic (038) titrated to effect over a five‐week phase with matched CR oxycodone arm. CONDITION: Chronic non‐cancer pain and bowel function ; Signs and Symptoms ; Pain, not elsewhere classified PRIMARY OUTCOME: Pain intensity and bowel function measured during the last week of treatment in each phase. SECONDARY OUTCOME: All assessments measured during the last week of treatment in each phase: ; 1. ROME‐III; 2. Patient Assessment of Constipation Symptoms (PAC‐SYM); 3. Brief Pain Inventory; 4. Multidimensional Pain Inventory; 5. Beck Depression Inventory; 6. Pain Disability Index; 7. Pain and Sleep Questionnaire ; 8. Level of Activity INCLUSION CRITERIA: 1. Male or non‐pregnant, non‐nursing female patients over the age of 18 years with chronic non‐cancer pain of moderate or greater intensity for at least three months 2. Patients who require stable doses of 60 to 80 mg every 12 hours of oxycodone or its analgesic equivalent 3. Patients experiencing less than three complete, spontaneous bowel movements in the seven days prior to randomisation