NL-OMON47313尚未招募2 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 - LP101-CL-201
yric Pharmaceuticals Inc.0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •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.
排除标准
- •Observation Phase:
- •Inability to obtain written informed consent to participate in the study from the patient or legally authorized representative.
- •Weight prior to ICU admission exceeding 150.0 kg.
- •Suspicion or confirmation of active bowel obstruction, perforation, or leakage.
- •History of esophageal or gastric surgery prior to or during the current hospital admission.
- •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.
- •Childs C cirrhosis (ALT elevations are not excluded in the Observation Phase, as these can resolve on follow-up);Efficacy Phase:
- •Inability to obtain written informed consent to participate in the study from the patient or legally authorized representative.
- •Weight prior to ICU admission exceeding 150.0 kg.
- •Suspicion or confirmation of active bowel obstruction, perforation, or leakage.
- •History of esophageal or gastric surgery prior to or during the current hospital admission.
- •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.].
- •QT interval corrected using Fridericia*s formula (QTcF) > 480 msec on a 12-lead ECG during screening.
- •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.
- •Childs C cirrhosis or ALT >= 1000 U/L
研究者
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