NCT00617552已完成2 期
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess Efficacy and Safety of TZP-101 When Administered as 30 Minute i.v. Infusion for POI to Subjects Undergoing Major Open Abdominal Surgery
Tranzyme, Inc.27 个研究点 分布在 3 个国家目标入组 267 人开始时间: 2007年7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
- 267
- 试验地点
- 27
- 主要终点
- Time to recovery of gastrointestinal function as defined by the time to first bowel movement.
研究概览
简要总结
The purpose of this study is to determine whether TZP-101 is effective in the management of post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large bowel resection).
详细描述
Subjects will be randomized according to an adaptive randomization procedure.
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
- •Subjects who meet all of the following inclusion criteria may be enrolled in the study:
- •Male or Female, 18 to 80 years of age, inclusive
- •If female, post-menopausal for the past 12 months, surgically sterile (i.e. tubal ligation, hysterectomy), or using an adequate method of birth control (i.e., oral contraceptives, double barrier method, IUD cover or sterilized partner
- •Subject is scheduled to undergo a partial large bowel resection with primary anastomosis - See Appendix II
- •Subject's body weight is ≤100kg
- •Subject is scheduled to receive postoperative pain management with i.v. opioids
- •Subject is scheduled to have nasogastric tube removed at the end of surgery
- •Subject is scheduled to be offered liquids on postoperative day 1
- •Subject is scheduled to be encouraged for ambulation on postoperative day 1
- •Subject is scheduled to be offered solid food on postoperative day 2
排除标准
- •Subjects who meet any of the following exclusion criteria may not be enrolled in the study:
- •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450(men)/ >470(women) milliseconds)
- •Subject has history of additional risk factors for Torsades de Pointes (heart failure, hypokalemia, family history of Long QT Syndrome)
- •Subject requires use of concomitant medication that prolongs the QT interval - List provided in Study Procedures Manual
- •Subject requires use of concomitant medication that is a known to interact with isoenzyme CYP3A4
- •Subject has complete bowel obstruction
- •Subject is scheduled to receive a thoracic epidural
- •Subject is scheduled to receive total colectomy, colostomy, or ileostomy
- •Subject is scheduled to receive a lower anterior resection
- •Subject is scheduled for laparoscopic procedure
- •Subject is scheduled to receive prophylactic antiemetics post surgery; however subjects may receive intraoperatively as part of the anesthesia protocol and postoperative antiemetics for symptomatic treatment
- •Subject has significant impairment of liver or renal function (ALT/AST 2 ½ times the upper limit of normal; creatinine clearance < 50mL/min.)
- •Subject has a psychiatric disorder or cognitive impairment that would interfere with participation in the study
- •Subject has severe cardiovascular, pulmonary, hematological diseases
- •Subject has participated in an investigational study 30 days prior or received TZP-101 90 days prior to the study initiation
- •Subject is pregnant (confirmed by quantitative serum pregnancy test) or is breast-feeding
- •Subject has a known history of Hep B, Hep C or HIV
- •Subject has a known history of drug or alcohol abuse
- •Subject has a recent, adult history of clinically significant hypersensitivity reaction(s) to any drug
研究组 & 干预措施
1
Placebo Comparator
干预措施: 5% dextrose in water (Drug)
2
Experimental
干预措施: TZP-101 (Drug)
3
Experimental
干预措施: TZP-101 (Drug)
4
Experimental
干预措施: TZP-101 (Drug)
5
Experimental
干预措施: TZP-101 (Drug)
6
Experimental
干预措施: TZP-101 (Drug)
7
Experimental
干预措施: TZP-101 (Drug)
8
Experimental
干预措施: TZP-101 (Drug)
结局指标
主要结局
Time to recovery of gastrointestinal function as defined by the time to first bowel movement.
时间窗: 7 days of dosing plus 7 days after administration of last dose
次要结局
- time to tolerance of first solid food(7 days post administration of last dose)
研究者
研究点 (27)
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