ISRCTN35931095已完成不适用
A randomised, placebo-controlled, titration-to-effect, crossover study of study drug 038 in patients with chronic low back pai
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
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 females at least 18 years of age
- •2. Chronic low back pain of at least moderate intensity for at least three months
- •3. Patients who require opioids to control their pain
排除标准
- •1. Patients who may require more than 12 tables of Tylenol No. 3 per day
- •2. Patients whose pain is expected to be refractory to opioid therapy
- •3. Patients with intolerance to study drug 038, acetaminophen or any other opioid
- •4. Patients with significant sources of unrelated pain that may obscure the assessment of efficacy
- •5. Patients with any of the following medical conditions:
- •5.1. Risk for central nervous system (CNS) and/or respiratory depression
- •5.3. Active inflammatory gastrointestinal disease
- •5.4. Peptic ulcer disease
- •5.5. Major psychiatric disorder
- •5.6. Any condition that may obscure patient safety or efficacy assessment
- •5.7. Patients who have received an investigational drug within the last month
研究者
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