EUCTR2006-004997-28-BG
进行中（未招募）
不适用
A randomized withdrawal, active- and placebo-controlled, double-blind, multi-center Phase III trial assessing safety and efficacy of oral CG5503 PR in subjects with moderate to severe chronic malignant tumor-related pain - n.a.
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- malignant tumor related pain
- 发起方
- Grünenthal GmbH
- 入组人数
- 432
- 状态
- 进行中（未招募）
- 最后更新
- 13年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Subjects must have signed an informed consent document indicating
- •that they understand the purpose of and procedures required for the
- •trial and are willing to participate in the trial.
- •Male and non\-pregnant, non\-lactating female subjects. Sexually
- •active women must be post menopausal, surgically sterile, or
- •practicing an effective method of birth control (e.g., prescription
- •oral contraceptives, contraceptive injections, intrauterine device,
- •double barrier method, contraceptive patch, male partner
- •sterilization) before entry and throughout the trial. Female subjects
- •of childbearing potential must have a negative pregnancy test at
排除标准
- •History of alcohol and/or drug abuse in the investigator’s judgment,
- •based on patient history and physical examination.
- •The subject has a clinically significant disease other than cancer
- •which in the investigator's opinion may affect efficacy or safety
- •assessments e.g., significant unstable cardiac, vascular, pulmonary,
- •gastrointestinal, endocrine, neurological, psychiatric (resulting in
- •disorientation, memory impairment or inability to report accurately)
- •or metabolic disturbances.
- •Any scheduled surgery during the trial.
- •Any painful procedure during the trial that may, in the opinion of the
结局指标
主要结局
未指定
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