Efficacy, Safety, and Pharmacokinetics (PK) Study of Ulimorelin in Patients With Enteral Feeding Intolerance (EFI): The PROMOTE Trial
NCT02784392 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2018-03-07
Summary
The purpose of this study is to evaluate the effect Ulimorelin in patients with enteral feeding intolerance.
Conditions
- Enteral Feeding Intolerance (EFI)
Interventions
- DRUG
-
Ulimorelin
Active
- DRUG
-
Metoclopramide
Comparator
Sponsors & Collaborators
-
Lyric Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
M Scott Harris, MD · Lyric Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2018-03-31
- Completion
- 2018-03-31
Countries
- United States
- Netherlands
- Spain
Study Locations
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