NL-OMON36404已完成3 期
Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain component - n.a.
Grunenthal0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Signed Informed consent. Male of female older then 18 years with severe chronic low back pain with a neuropathic component, for at least 3 months. Using a step II of III analgetic for at least 2 weeks before enrollment. When treatment with step II analgetics the pain must be 5 or higher for the last 3 days before enrollment. When using a step I analgetic a pain of 6 or higher must be scored.Woman of childbearing potential must be using birthcontrol, must have a negative pregnancy test and no breastfeeding allowed.
排除标准
- •alcohol or drug abuse, presence of systemic or local infections, hypersensitivity of tapentadol, participation in another trial, use of MAO inhibitors within 14 days before enrollment, non-stable dosing SSRI's. Presence of clinically significant disease of laboratory findings that according to the investigator effect safety and efficacy.
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