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临床试验/NCT00800527
NCT00800527已完成4 期

Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

Usak State Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Reduction of pain or paresthesia severity

研究概览

简要总结

In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain syndromes.

详细描述

Because the primary objective of this study is to evaluate the effect of different drugs on chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end point design for this study. According to this design, both patients and physicians making first assessment are aware of the treatment but the investigators making second and third assessment are blinded to treatment. Therefore, two separate cardiovascular surgeons wil select and randomize the patients and a cardiologist blinded to treatment assignments will evaluate the patients at second interview at thirty day and 3 months later. The study was approved by the Local Ethics Committee and informed consent was obtained from each patient. The study was conducted in Usak State Hospital with collaboration the Department of Cardiology of Ataturk Education and Training Hospital.

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
None

入排标准

年龄范围
15 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Poststernotomy chest pain and/or paresthesia

排除标准

  • Osteoporosis, renal function impairment (creatinine value >1.5 mg / dl.)
  • Hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases
  • Over production of scar tissue, thoracic surgery other than sternotomy -
  • Redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass

研究组 & 干预措施

1

Active Comparator

Gabapentin

干预措施: Gabapentin (Drug)

2

Active Comparator

Diclofenac

干预措施: Diclofenac (Drug)

结局指标

主要结局

Reduction of pain or paresthesia severity

时间窗: one month

次要结局

  • duration of relief of pain or paresthesia(three month)

研究者

发起方
Usak State Hospital
申办方类型
Other

研究点 (1)

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