NCT02573922已完成4 期
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
Kuopio University Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2012年5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
- 180
- 试验地点
- 1
- 主要终点
- opioid induced constipation
研究概览
简要总结
In the present study, the primary aim was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced opioid induced constipation in patients with or without chronic opioid treatment undergoing spine surgery.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 17 - 35 kg/m2
- •elective spine surgery
- •informed consent obtained
排除标准
- •allergy to the used drugs
- •other contraindication to oxycodone medication
- •no informed consent
研究组 & 干预措施
Oxycodone-naloxone
Experimental
Oxycodone-naloxone prolonged release tablet twice a day
干预措施: oxycodone-naloxone (Drug)
Oxycodone
Active Comparator
Oxycodone prolonged release tablet twice a day
干预措施: Oxycodone (Drug)
结局指标
主要结局
opioid induced constipation
时间窗: from the surgery up to 21 days
Opioid induced constipation was assessed with bowel function index
次要结局
未报告次要终点
研究者
Merja Kokki
MD, PhD
Kuopio University Hospital
研究点 (1)
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