NCT00267358已完成2 期
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 19
- 主要终点
- Functional performance
研究概览
简要总结
Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling patients ≥ 18 years of age with incurable,histologically diagnosed cancer.
- •Involuntary loss of body weight of ≥ 5 % within the past 6 months
排除标准
- •Presently hospitalized or in a nursing care facility.
- •Inability to increase food intake from secondary causes.
- •Liver disease
- •If female-pregnant, breast-feeding or of childbearing potential.
研究组 & 干预措施
RC-1291 HCl
Active Comparator
50 mg
干预措施: RC-1291 HCl (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Functional performance
Body weight
Lean body mass
次要结局
未报告次要终点
研究者
研究点 (19)
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