NCT00672074已完成2 期
A Phase II, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Management of Post-Operative Ileus in Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 19
- 主要终点
- Recovery of GI function
研究概览
简要总结
The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.
详细描述
The safety and efficacy of ipamorelin in the management of post-operative ileus
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willing to comply with protocol
- •undergoing bowel resection surgery
- •ASA Class I-III
- •Females must not be pregnant
- •Body weight 40-150 kg
排除标准
- •mentally incompetent or unable to provide informed consent
- •clinically unstable
- •significant liver disease
- •clinically significant lab or EKG abnormalities
- •alcohol or illicit drug abuse
- •history of or current surgery that would prevent proper evaluation of safety or efficacy of drug
研究组 & 干预措施
1 Ipamorelin
Active Comparator
干预措施: Ipamorelin (Drug)
2 Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Recovery of GI function
时间窗: Until hospital discharge
次要结局
未报告次要终点
研究者
研究点 (19)
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