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
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Chronic low back pain
- 发起方
- Purdue Pharma Canada
- 入组人数
- 100
- 状态
- 已完成
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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