EUCTR2016-000723-94-NL进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Intravenous Ulimorelin (LP101) in Patients with Enteral Feeding Intolerance
yric Pharmaceuticals, Inc.0 个研究点目标入组 122 人开始时间: 2016年5月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Observation Phase
- •Men and non-pregnant women aged 18 years and above
- •Intubated and mechanically ventilated in the ICU
- •Receiving continuous nasogastric, orogastric, or percutaneous gastric tube feedings
- •A 12-Fr or larger nasogastric, orogastric, or percutaneous gastric feeding tube, with its distal tip at least 10 cm below the gastroesophageal junction and visible in the stomach on a routine radiographic examination within 24 hours of screening
- •At risk for the development EFI, with risk defined as GRV between 300 mL and 499 mL on one or more measurements
- •Expected to remain intubated, mechanically ventilated, and receiving nasogastric orogastric or percutaneous feeding for at least 48 hours
- •Efficacy Phase
- •Men and non-pregnant women aged 18 years and above
- •Intubated and mechanically ventilated in the ICU
- •Receiving continuous nasogastric, orogastric, or percutaneous gastric tube feeding, with no contraindication to advancing feedings per the feeding protocol
- •A 12-Fr or larger nasogastric, orogastric, or percutaneous gastric feeding tube, with its distal tip at least 10 cm below the gastroesophageal junction and visible in the stomach on a routine radiographic examination within 24 hours of screening
- •Enteral feeding intolerance, defined as a GRV of = 500 mL on one or more measurements
- •Expected to remain intubated, mechanically ventilated, and receiving nasogastric orogastric or percutaneous feeding for at least 48 hours
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 115
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Observation Phase
- •1.Inability to obtain written informed consent to participate in the study from the patient or legally authorized representative. 2.Weight prior to ICU admission exceeding 150.0 kg. 3.Suspicion or confirmation of active bowel obstruction, perforation, or leakage. 4.History of esophageal or gastric surgery prior to or during the current hospital admission. 5.Patient’s clinical condition is deteriorating rapidly, or the Investigator does not consider there to be a reasonable expectation that the patient will complete the study. 6.Childs C cirrhosis (ALT elevations are not excluded in the Observation Phase, as these can resolve on follow-up)
- •Efficacy Phase
- •1.Inability to obtain written informed consent to participate in the study from the patient or legally authorized representative. (Whenever possible, patients who participate based on proxy consent will be re-consented once deemed capable by the Investigator of providing consent on their own.) 2.Weight prior to ICU admission exceeding 150.0 kg. 3.Suspicion or confirmation of active bowel obstruction, perforation, or leakage. 4.History of esophageal or gastric surgery prior to or during the current hospital admission. 5.Use of any of the following prokinetic medications is allowed until 48 hours before randomisation but prohibited from 48 hours prior to randomisation through the 5 days of treatment with study drug: domperidone, cisapride, neostigmine, or opioid antagonists, including alvimopan, naloxone, naltrexone, or analogs of naloxone or naltrexone; erythromycin or azithromycin. [N.B., azithromycin is permitted for treatment of pulmonary infections up to 48 hours before randomization, but not thereafter through Day 5. Up to 2 doses of metoclopramide are permitted within 48 hours of randomisation, provided that metaclopramide is not administered within 10 hours of the first dose of study drug or at any time through Day 5. If a patient receives metoclopramide during the screening period, a radiologic examination must confirm that the feeding tube remains visible in the stomach after the final dose of drug during screening and prior to the start of baseline gastric emptying measurements and has not migrated to the duodenum. Use of clarithromycin for any indication is not excluded.]. 6.QT interval corrected using Fridericia’s formula (QTcF) > 480 msec on a 12-lead ECG during screening. 7. Patient’s clinical condition is deteriorating rapidly, or the Investigator does not consider there to be a reasonable expectation that the patient will complete the study. 8.Childs C cirrhosis or ALT = 1000 U/L
研究者
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