Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-02-04 @ 4:05 PM
Study NCT ID:
NCT02784392
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Pharmacokinetics (PK) Study of Ulimorelin in Patients With Enteral Feeding Intolerance (EFI): The PROMOTE Trial
Sponsor:
Lyric Pharmaceuticals
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMOTE
Brief Summary:
The purpose of this study is to evaluate the effect Ulimorelin in patients with enteral feeding intolerance.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-000723-94 | EUDRACT_NUMBER | None | View |