NCT00002996已完成2 期
Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
研究概览
简要总结
RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.
PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.
详细描述
OBJECTIVES:
- Investigate the effectiveness of flecainide in the management of neuropathic pain.
OUTLINE: Patients are given a brief pain inventory (BPI) form to assess their pain upon enrollment in the study. Following a 7 day stabilization period, flecainide is administered. One capsule of flecainide is given twice a day on days 8-10, two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21. BPI forms are completed on days 8, 15 and 22 to assess neuropathic pain.
PROJECTED ACCRUAL: A total of 7-20 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Chronic neuropathic pain with diagnosis of cancer or AIDS
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •SGOT no greater than 2 times upper limit of normal (ULN)
- •Creatinine no greater than 2 times ULN
- •Cardiovascular:
- •No clinical history of infarction or angina
- •No advanced heart failure
- •No sick sinus syndrome, intraventricular conduction disease, second or third degree AV block or arrhythmias requiring treatment (exception may be granted by cardiac consult)
- •No focal wall motion abnormalities
- •Ejection fraction at least 40%
- •Systolic blood pressure at least 90 mm Hg
- •Must be able to take oral medication
- •No known allergy or adverse reaction to flecainide, mexilitene or any other type I antiarrhythmic drug
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 2 weeks since prior chemotherapy that may cause neuropathy
- •Endocrine therapy:
- •At least 2 weeks since prior corticosteroids
- •Radiotherapy:
- •Not specified
- •Not specified
- •No tricyclic antidepressant treatment within past 2 weeks
- •No concurrent use of flecainide, mexiletene or any other type I antiarrhythmic drug
排除标准
- 未提供
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord InjurySpinal Cord InjuriesPainNeuropathic PainNCT00167856US Department of Veterans Affairs16
已完成
不适用
Effects of Pennsaid on Clinical Neuropathic PainNeuralgiaComplex Regional Pain Syndrome (CRPS)Reflex Sympathetic DystrophyPostherpetic NeuralgiaNCT01508676Massachusetts General Hospital35
已完成
2 期
Clonidine Versus Adenosine to Treat Neuropathic PainPainNCT00349921Wake Forest University Health Sciences24
Unknown
1 期
a Safety and Tolerability Study of EP-9001A in Healthy VolunteersHealthy VolunteersNCT05278611Chengdu Easton Biopharmaceuticals Co,Ltd44
已完成
不适用
Study of Possible Changes in QST After Application of Capsaicin on Patients With Peripheral Neuropathic PainPeripheral Nerve InjuryPostherpetic NeuralgiaNCT01596491Ruhr University of Bochum20