NCT01278004已完成2 期
A Randomised Double-blind Placebo-controlled Trial of the Safety and Efficacy of Ethosuximide 250mg Capsules for the Management of Chemotherapy Induced Painful Peripheral Neuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
研究概览
简要总结
This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive substance) to test whether any response is a true effect of the drug, and not a 'placebo effect'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Age >/= 18
- •Diagnosis of cancer
- •Willing and able to give informed consent to the CIN-E study and complete study questionnaires, this involves adequate understanding of written and spoken English (translators will not be used)
- •Chemotherapy-induced painful peripheral neuropathy as diagnosed by score of >12 on the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) with a pain intensity rating of >4, on a 11 point numeric rating scale (0= no pain, 10= worst possible pain).
- •Duration of chemotherapy-induced painful peripheral neuropathy >4 weeks. Participant may either have completed chemotherapy, or be receiving ongoing chemotherapy.
- •Able to attend research centre according to the required visit schedule.
- •Diet allows bovine gelatine (present in both ethosuximide and placebo capsules)
- •Women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence.
排除标准
- •Renal impairment (serum creatinine >1.5x normal level)
- •Deranged liver function (AST>3x normal level)
- •Patients currently taking any anti-depressant medication, for example fluoxetine, paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week.
- •Patients currently taking any other anti-epileptic drug, including gabapentin, or within the past week.
- •Pregnancy
- •Allergy to succinimides, ethosuximide, methsuximide, phensuximide. Pre-exisitng painful peripheral neuropathy of any other cause.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo capsule
干预措施: Placebo (Drug)
Drug
Experimental
干预措施: Ethosuximide (Drug)
结局指标
主要结局
Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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