NCT01296620已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection
Tranzyme, Inc.50 个研究点 分布在 6 个国家目标入组 330 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 50
- 主要终点
- Recovery of GI Function
研究概览
简要总结
Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, 18 to 80 years of age, inclusive
- •Scheduled to undergo open bowel resection with colonic anastomosis
- •For women who can potentially become pregnant a pregnancy test at screening and admission must be negative
排除标准
- •Weight more than 200kg (441 pounds)
- •Pregnant or breastfeeding
- •Known history of drug or alcohol abuse within the previous year
研究组 & 干预措施
Experimental 1
Experimental
干预措施: Ulimorelin Intravenously (IV) (Drug)
Experimental 2
Experimental
干预措施: Ulimorelin Invtravenously (IV) (Drug)
Placebo
Placebo Comparator
干预措施: 5% dextrose in water (Drug)
结局指标
主要结局
Recovery of GI Function
时间窗: up to 7 days of dosing or until hospital discharge
次要结局
- Ancillary GI Functions(up to 7 days of dosing or hospital discharge)
研究者
研究点 (50)
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