NCT02125981已完成3 期
A Prospective Randomized Double-blinded Clinical Trial About the Efficacy of Oral Limaprost Administration Following Surgery for Cervical Myelopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Japanese Orthopedic Association (JOA) recovery rates
研究概览
简要总结
The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 20 years old
- •Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
- •Plan to undergo cervical surgery for myelopathy
- •JOA score less than 15 points
- •Signed informed consent of patient or legal guardian
排除标准
- •Infection or malignancy
- •Taking Limaprost before surgery
- •Pregnancy or expected to be pregnant or breast feeding
- •severe cardiovascular, pulmonary, renal disease or distress, brain pathology
- •any related coagulopathy
- •any drug to cause bleeding tendency
- •severe pain from other disease
- •any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study
- •patient cannot follow study protocol, for any reason
研究组 & 干预措施
Limaprost
Experimental
taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
干预措施: Limaprost (Drug)
Control
Placebo Comparator
taking placebo drug
干预措施: Placebo (Drug)
结局指标
主要结局
Japanese Orthopedic Association (JOA) recovery rates
时间窗: up to 12 months after operation
JOA recovery rate = \[(postoperative JOA score) - (preoperative JOA score)\] / \[(17-(preoperative JOA score)\] x 100 (%).
次要结局
- Visual Analog Pain Scale for neck pain(up to 12 months after operation)
- Neck disability index score(up to 12 months after operation)
- Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score(up to 12 months after operation)
- Questionnaire Short Form 12(up to 12 months after operation)
- Japanese orthopaedic association score(up to 12 months after surgery)
- assessment of the efficacy of positron emission tomography (PET)(up to 12 months after operation)
研究者
Jin S. Yeom
Professor
Seoul National University Hospital
研究点 (1)
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