CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 74 enrolled
Drug / intervention
Lipidem +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03282955
NCT03282955Phase 4Completed
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A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion

B. Braun Melsungen AG·interventional·Posted Sep 14, 2017·Updated Jul 4, 2025

In Brief

A Phase 4 clinical trial evaluating Lipidem and Lipofundin MCT 20% for Patients Requiring Home Parenteral Nutrition. Completed, enrolled 74 participants across 9 sites in 5 countries.

Detailed Summary

The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPatients Requiring Home Parenteral Nutrition
CountriesFrance, Italy, Netherlands, Poland, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedSep 14, 2017
Enrollment StartJan 8, 2018
Primary CompletionJul 19, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8.8 years ago

Interventions

Lipidemdrug

Lipoplus i.v. lipid emulsion for parenteral nutrition

Lipofundin MCT 20%drug

Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition