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

Purdue Pharma Canada0 个研究点目标入组 80 人开始时间: 2009年1月8日最近更新: 2015年1月13日

适应症

试验速览

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•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

•1. Patients who undergoing any treatments that may change their pain during the study, such as physiotherapy, corticosteroid injections or surgical procedures
•2. Patients who do not respond adequately to doses of 60 or 80 mg every 12 hours of oxycodone
•3. Patients whose pain is expected to be refractory to continuous opioid therapy
•4. Patients with allergy to study drug 038, oxycodone or any other opioid
•5. Patients with any of the following:
•5.1. A condition that affects patient safety or obscures the assessment of efficacy
•5.2. Compromised kidney or liver function
•5.3. Risk for central nervous system (CNS) and/or respiratory depression
•5.4. Significant gastrointestinal structural abnormalities or diseases/conditions that affect bowel function
•5.5. A major psychiatric disorder
•5.6. Received an investigational drug in the last month
•5.7. Failed the urine drug screen

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