TCTR20140418002招募中4 期
Gabapentin as an Adjuvant Analgesic with Opioids for the Management of Metastatic Bone Pain: Randomized, Double-Blind, Placebo-Controlled Crossover Trial
The Medical Association of Thailand0 个研究点目标入组 32 人开始时间: 2014年4月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
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
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1 Age 8805 18 years
- •2 Malignant tumors with at least one metastatic bone lesion and bone pain
- •is the major pain
- •Bone metastasis is established by radiographic confirmation CT scan MRI nuclear scan
- •3 Numerical Rating Scale 8805 4 NRS from 0 to 10 in 24 hour period
- •preceding the screening visit
- •4 Life expectancy 8805 30 days and Palliative Performance Scale PPS 8805 30
- •5 Regularly scheduled and stable dose of basal opioids medication for at
- •least 24 hours
- •Stable opioid use is defined as taking a constant daily dose of MSS 8804 3 dose day as rescue medication
- •6 No opioid related side effects 8804 Grade 2 of Cancer Therapy Evaluation
- •Program Common Terminology Criteria for Adverse Events CTCAE
- •Version 4 0
排除标准
- •1 Hypersensitivity to gabapentin
- •2 Unable take oral medication
- •3 Creatinine clearance 60 mL min calculated by the Cockcroft Gault
- •4 Current gabapentin or pregabalin use within 5 days prior to screening
- •5 Pathologic fracture clinical or radiographic evidence of spinal
- •cord compression or cauda equina syndrome
- •6 Chemotherapy from 2 weeks before screening throughout the study
- •7 Radiotherapy to the pain producing lesion from 1 month before
- •screening throughout the study
- •8 New hormone therapy or increase the dose during the study
- •9 New bisphosphonate therapy over the course of study
研究者
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