NCT01953081已完成1 期
A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance
Takeda1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This study is being conducted to evaluate the safety, tolerability and early efficacy of IV TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are admitted to the intensive care require mechanical ventilation, and are intolerant to enteral feeding.
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
- •Intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study
- •Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV measurement ≥250 mL within the 24 hours before randomization
排除标准
- •History of diabetic or idiopathic gastroparesis
- •Screening blood glucose >15 mmol/L (270 mg/dL) while receiving insulin
- •Impaired renal function, as defined by estimated glomerular filtration rate (eGFR) <30 mL/min, as determined by the Cockcroft-Gault formula -Bilirubin concentration in blood >2 times the upper limit of normal
- •ALT or AST >3 times upper limit of normal
- •Alkaline phosphatase >2 times upper limit of normal
- •Contraindication to enteral feeding
- •Opioid or other drug overdose as the primary reason for admission to Intensive Care Unit (ICU)
- •Receipt of a drug that can be used as a gastric prokinetic agent
- •Receipt of agents known to directly influence the 5 HT4/acetylcholine prokinetic mechanism
研究组 & 干预措施
TD-8954
Experimental
TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
干预措施: TD-8954 (Drug)
Metoclopramide
Active Comparator
Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
干预措施: Metoclopramide (Drug)
结局指标
主要结局
Adverse Events
时间窗: 6 Days
the number of subjects reporting adverse events by treatment group
Gastric Retention by Scintigraphy
时间窗: 180 minutes
Number of subjects with retention less than 13% at 180 minutes after dosing.
次要结局
- Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose(120 minutes)
- Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose(240 minutes)
- Tmax(72 hours)
- AUC(72 hours)
- Cmax(72 hours)
- Gastric Emptying by Breath Test(180 minutes)
- Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose(60 minutes)
研究者
研究点 (1)
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