NCT01285570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.45 个研究点 分布在 7 个国家目标入组 332 人开始时间: 2011年1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
- 332
- 试验地点
- 45
- 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 2
Experimental
干预措施: Ulimorelin Intravenously (IV) (Drug)
experimental 1
Experimental
干预措施: Ulimorelin Intravenously (IV) (Drug)
Placebo
Placebo Comparator
Placebo comparator daily (QD)
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 (45)
Loading locations...
相似试验
已完成
3 期
Ulimorelin Study of Efficacy and Safety (ULISES 008)Gastrointestinal DysmotilityNCT01296620Tranzyme, Inc.330
已完成
2 期
Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal FunctionGastrointestinal DysmotilityNCT01280344Helsinn Therapeutics (U.S.), Inc320
已完成
2 期
Efficacy, Safety, and Pharmacokinetics (PK) Study of Ulimorelin in Patients With Enteral Feeding Intolerance (EFI): The PROMOTE TrialEnteral Feeding Intolerance (EFI)NCT02784392Lyric Pharmaceuticals120
已完成
4 期
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical CystectomyPostoperative IleusNCT00708201Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)280
撤回
1 期
A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese SubjectsObesityNCT01472848Pfizer