CTRI/2011/12/002182已完成3 期
Role of gabapentin as adjuvant analgesic with opioids for neuropathic cancer pain when combined with low dose amitriptyline in cancer subjects of Tripura, a North Eastern state of India. - Nil
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a.Age 18 years to 80 years
- •b.Cancer Patients with neuropathic pain not controlled with opioid analgesics.
- •c.Worst pain intensity >= 5 on a NRS from 0 â?? 10, in the 24 hour period to study entry.
- •d.Stable dose of regularly scheduled systemic opioid therapy (Morphine >= 60 mg / 24 hour without sufficient analgesia for at least 24 hour.
- •e.Life expectancy >= 30 days.
- •f.Karnofsky performance status (KPS) >= 40.
排除标准
- •a.Serum creatinine 2 times the upper limit of normal.
- •b.Serum liver enzyme 5 times the upper limit of normal.
- •c.Serum sodium 130 m Eq.
- •d.Unable to take medication orally.
- •e.Pregnant and lactating subjects.
- •f.Other organ dysfunction.
- •g.Chemotherapy from 3 days before screening.
- •h.Radiotherapy to the pain producing lesion from 15 days before screening.
- •i.Patients unable to communicate fluency in Bengali Hindi or English.
- •j.Patients with history of epilepsy or use of anti epileptic drugs or neuropathic analgesics other than opioids.
研究者
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