Enteral Feeding Intolerance MedDRA version: 19.0 Level: LLT Classification code 10074293 Term: Enteral feeding intolerance System Organ Class: 100000004861
Conditions
Interventions
Product Name: Ulimorelin
Product Code: LP101
Pharmaceutical Form: Injection
INN or Proposed INN: Ulimorelin
Current Sponsor code: LP101
Other descriptive name: ULIMORELIN HYDROCHLORIDE MONOHYDRATE
Con
Sponsors
Lyric Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men and non-pregnant women aged 18 years and above 2.Intubated and mechanically ventilated in the ICU 3.Receiving continuous nasogastric, orogastric, or percutaneous gastric tube feeding, with no contraindication to advancing feedings per the feeding protocol (Appendix 9.5) 4.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 5.Enteral feeding intolerance, defined as a GRV of = 500 mL on one or more measurements [N.B., a follow-on GRV =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 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.Prior use during the current ICU admission of parenteral nutrition or trophic feeding defined as a prescription to receive = 20 mL/hr of enteral feeding for more than 24 hrs prior to screening [N.B., parenteral nutrition may be initiated post randomization provided that the supplemental nutrition is coordinated with the calories and protein targets of the PTV and reduced as enteral feeding is advanced] 3.Weight prior to ICU admission exceeding 150.0 kg 4.Positive serum pregnancy test at screening in women of child-bearing potential (a serum pregnancy test needs to be performed only once and does not need to be repeated prior to randomization) N.B., Women of child-bearing potential must abstain from sexual intercourse or use effective birth control methods for 1 month after their participation in the study ends. Men with a female partner capable of having children must abstain from sexual intercourse or use effective birth control methods for 3 months after their participation in the study ends (see Section 3.5.2.11). 5.Suspicion or confirmation of active bowel obstruction, perforation, or leakage 6.History of esophageal or gastric surgery prior to or during the current hospital admission 7.History of diabetic, neurogenic, or idiopathic gastroparesis (patients will only be excluded if one of these disorders is documented in the medical record prior to admission to the ICU) 8.Conditions associated with excessive GH secretion, including but not limited to acromegaly 9.Opioid overdose or poly pharmacy drug overdose as the primary reason for admission to the ICU 10.Use of any of the following prokinetic medications during the current ICU admission and through Day 5: 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, provided that drug 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.] Propofol must be discontinued before screening. However, its use may be permitted under special conditions subsequent to the first dose of study drug but not in excess of 12 hours cumulative administration over the 5-day study period. (See Section 3.4.10.2) 11.Known allergy or intolerance to metoclopramide or paracetamol 12.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 13.Childs C cirrhosis or ALT = 1000 U/L 14.Advanced or end-stage malignancy 15.Patient has participated in another study involving an investigational drug or device within t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of multiple daily intravenous (IV) doses of ulimorelin on the proportion of the target daily protein received through enteral nutrition by mechanically ventilated and tube-fed patients with enteral feeding intolerance (EFI);Secondary Objective: To evaluate the efficacy of multiple daily IV doses of ulimorelin on the proportion of the target daily calories received through enteral nutrition by mechanically ventilated and tube-fed patients with EFI;Primary end point(s): Primary Efficacy Endpoint: The daily average (mean) percentage of target daily protein received through enteral nutrition by mechanically ventilated and tube-fed patients with EFI, Days 1 through 5.;Timepoint(s) of evaluation of this end point: Day 1 to Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoint: The daily average (mean) percentage of target daily calories received through enteral nutrition by mechanically ventilated and tube-fed patients with EFI, Days 1 through 5;Timepoint(s) of evaluation of this end point: Days 1 through Day 5 | — |
Countries
Netherlands, Spain, United States
Contacts
Public ContactPaz González
Pivotal, S.L.
Outcome results
None listed