NCT01526564已完成3 期
Phase III Study of Acetyl-L-Carnitine (ALC) Hydrochloride Enteric-coated Tablets in Treatment of Peripheral Sensory Neuropathy in Anti-cancer Chemotherapeutics Induce
Lee's Pharmaceutical Limited0 个研究点目标入组 239 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 主要终点
- Changes in peripheral sensory neuropathy grades
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse drug reaction, and the primary manifestations are different degree of neuromotor, sensorineural and autonomic nervous dysfunction.
详细描述
This multicenter, randomized, double-blind, placebo-controlled and parallel clinical trial is to observe the efficacy and safety of the Acetyl-L-Carnitine Hydrochloride enteric-coated tablets in treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics induce.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Weeks 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had signed the Informed Consent Form
- •Male or Female
- •Age 18-75 years old
- •Patients who have treated with Taxoids, Satraplatin and Vincristine; The peripheral sensory neuropathy grading after chemotherapy was >/=grade 3 or grade 2 lasting for one month
- •The course of neuropathy was </=6 months
- •No need to continue chemotherapy according to the condition nor refusing chemotherapy
- •At least one of the neuroelectrophysiological examine results were abnormal
- •Physical Condition Score (KPS) >/=60
- •Anticipated lifetime>/=60.
排除标准
- •Patients whose peripheral sensory neuropathy was induced by medicines except of the Taxoids, Satraplatin and vincristine anti-cancer chemotherapeutics
- •Diabetics
- •Peripheral sensory neuropathy was induced by Vitamin deficiency, infections, trauma, toxicosis, compression, and ischemia
- •Peripheral sensory neurologic dysfunction that induced by lesions of central nervous system; hereditary neuropathy
- •Patients who have treated by other medicines for peripheral sensory neuropathy in 30 days
- •Patients had treated by other clinical trial medicines or participated into other trials in 30 days
- •Patients had active infections
- •Any clinical problems out of control
- •Women in pregnancy and lactation, Subjects with no compliance.
研究组 & 干预措施
ALC
Active Comparator
ALC
干预措施: Acetylcarnitine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in peripheral sensory neuropathy grades
时间窗: Base and eighth week
Changes in peripheral sensory neuropathy grades after eight weeks treatment
次要结局
- Changes in Neuroelectrophysiological test(Base and eighth week)
- Changes in Cancer-related fatigue level(Base and eighth week)
- Changes in Physical Condition Score(Base and eighth week)
研究者
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