ISRCTN54273961已完成不适用
Phase III, randomized, double-blind, active-controlled, parallel arm study of PRC-062 in patients with chronic non-cancer pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or non-pregnant, non-nursing female subjects of 18 years of age or older
- •2. History of chronic non-cancer pain for six months or more
- •3. Subjects who at time of screening require stable doses of CR hydromorphone not exceeding 60 mg per day for a period of three months or more prior to entry into the study and who report satisfaction with their pain management
排除标准
- •1. Subjects who do not respond adequately to on-label dosing of CR hydromorphone at doses not exceeding 60 mg per day
- •2. Subjects with cancer
- •3. Inhaled cannabis use
- •4. Compromised kidney or liver function
- •5. Conditions that may adversely affect safety or obscure the assessment of efficacy
- •6. Risk for central nervous system (CNS) or respiratory depression
- •7. Significant gastrointestinal (GI) structural abnormalities or diseases/conditions that may affect bowel function
- •8. Major psychiatric disorder
- •9. Received an investigational drug in the past month
- •10. Taking monoamine oxidase (MAO) inhibitors
研究者
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