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Trial record 2 of 3 for:    lp101

Efficacy, Safety, and Pharmacokinetics (PK) Study of Ulimorelin in Patients With Enteral Feeding Intolerance (EFI): The PROMOTE Trial (PROMOTE)

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ClinicalTrials.gov Identifier: NCT02784392
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Lyric Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the effect Ulimorelin in patients with enteral feeding intolerance.

Condition or disease Intervention/treatment Phase
Enteral Feeding Intolerance (EFI) Drug: Ulimorelin Drug: Metoclopramide Phase 2

Detailed Description:
This is a multicenter, randomized, double-blind, comparator-controlled study. The study consists of 2 parallel-dose treatment groups consisting of ulimorelin and metoclopramide. Approximately 120 mechanically ventilated, tube-fed patients with EFI will participate in this trial. To be eligible for study participation, the patients must be intolerant to continuous gastric tube feedings, with intolerance defined as having a gastric residual volume (GRV) of ≥ 500 mL on one or more measurements.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 (EFI)
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
Ulimorelin
Drug: Ulimorelin
Active

Active Comparator: Comparator
Metoclopramide
Drug: Metoclopramide
Comparator




Primary Outcome Measures :
  1. 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 [ Time Frame: 5 Days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 5 Days ]

Other Outcome Measures:
  1. Serious Adverse Events (SAEs) and Adverse Events (AEs), summarized by treatment group and Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) and preferred term. [ Time Frame: 8 days ]
  2. Clinical laboratory tests, summarized by treatment group [ Time Frame: 6 days ]
  3. Electrocardiogram (ECGs), summarized by treatment group [ Time Frame: 5 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 feeding for at least 72 hours

Exclusion Criteria:

  • Inability to obtain written informed consent to participate in the study from the patient or legally authorized representative
  • 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 hours 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 Prescribed Total Volume (PTV) and reduced as enteral feeding is advanced]
  • 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 during the current ICU admission: 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 to 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 circumstances subsequent to the first dose of study drug but not in excess of 12 hours administration over the 5-day study period.]
  • 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 Alanine Aminotransferase (ALT) ≥1000 U/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784392


Locations
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United States, Louisiana
New Orleans, Louisiana, United States
United States, Ohio
Columbus, Ohio, United States
Netherlands
Amsterdam, Netherlands
Spain
Barcelona, Spain
Madrid, Spain
Sponsors and Collaborators
Lyric Pharmaceuticals
Investigators
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Study Director: M Scott Harris, MD Lyric Pharmaceuticals

Additional Information:
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Responsible Party: Lyric Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02784392     History of Changes
Other Study ID Numbers: LP101-CL-201
2016-000723-94 ( EudraCT Number )
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action