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

NCT02784392 | Completed Phase 2 DMC

• 2 other identifiers: LP101-CL-2012016-000723-94
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Enteral Feeding Intolerance (EFI)

Outcome Measures

Primary Outcomes (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

  5 Days

Secondary Outcomes (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

  5 Days

Other Outcomes (3)

• 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.

  8 days

• Clinical laboratory tests, summarized by treatment group

  6 days

• Electrocardiogram (ECGs), summarized by treatment group

  5 days

Study Arms (2)

Active

EXPERIMENTAL

Ulimorelin

Drug: Ulimorelin

Comparator

ACTIVE COMPARATOR

Metoclopramide

Drug: Metoclopramide

Interventions

Ulimorelin DRUG

Active

Active

Metoclopramide DRUG

Comparator

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lyric Pharmaceuticals: lead

Study Sites (5)

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Related Links

• Related Info

MeSH Terms

Interventions

ulimorelin; Metoclopramide

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• M Scott Harris, MD

  Lyric Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 27, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

NL (1); US (2); ES (2)