NCT01624571已完成2 期
A Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel, Phase II Clinical Trial to Assess the Effect on Recovery of GI Motility and Safety and to Determine the Optimal Dose of LD02GIFRO in Patients Undergoing Colon Resection
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Improvement of gastrointestinal motility
研究概览
简要总结
This clinical trial is conducted to determine the optimal dose of LD02GIFRO in improvement of gastrointestinal motility between each dose group by comparing the effectiveness and safety in patients undergoing colon resection.
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
- •≥ 20 years
- •Subject is scheduled for a partial colon resection with primary anastomosis via laparotomy
- •Subject is scheduled to receive primary postoperative pain management with intravenous patient-controlled analgesia (PCA) opioids
排除标准
- •Subject is scheduled for a total colectomy, colostomy, ileostomy
- •Subject has complete bowel obstruction
- •Subject is scheduled for laparoscopic surgery
研究组 & 干预措施
Placebo
Placebo Comparator
Control Group
干预措施: LD02GIFRO (Drug)
Group 1
Experimental
300mg/day
干预措施: LD02GIFRO (Drug)
Group 2
Experimental
600mg/day
干预措施: LD02GIFRO (Drug)
Group 3
Experimental
900mg/day
干预措施: LD02GIFRO (Drug)
结局指标
主要结局
Improvement of gastrointestinal motility
时间窗: in hospitalization (Maximized 14 days)
Evaluation gastrointestinal function to the time of improvement gastrointestinal motility
次要结局
未报告次要终点
研究者
研究点 (1)
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