临床试验/NCT00219817

NCT00219817已完成2 期

Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss

Helsinn Therapeutics (U.S.), Inc13 个研究点分布在 1 个国家目标入组 80 人开始时间: 2005年6月最近更新: 2013年9月2日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Helsinn Therapeutics (U.S.), Inc
入组人数: 80
试验地点: 13
主要终点: Body Weight

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Anorexia and weight loss 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 weight loss. This study will test the safety and efficacy of RC-1291 in the treatment of cancer patients with anorexia and weight loss.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
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.

结局指标

主要结局

Body Weight

Lean Body Mass

Functional Performance

次要结局

未报告次要终点

研究者

发起方

Helsinn Therapeutics (U.S.), Inc

申办方类型

Industry

研究点 (13)

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