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NCT03563222 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
A Phase 4 study, sponsored by Fresenius Kabi.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT03563222 is a Phase 4 study that was terminated before completion, run by Fresenius Kabi. The registered enrollment target is 1 participants.
The verdict
NCT03563222, a Phase 4 study, was terminated before completion, sponsored by Fresenius Kabi.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.
Interventions
- DRUG Smoflipid
- DRUG Intralipid, 20%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-12-18 |
| Est. Completion | 2022-07-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03563222
The ClinicalTrials.gov registry entry for NCT03563222 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fresenius Kabi, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Smoflipid is the first listed.
NCT03563222 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03563222 about?
NCT03563222 is a clinical study titled "Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age". Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.
What is the current status of trial NCT03563222?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2019-12-18. Estimated completion is 2022-07-08.
What interventions are being tested in trial NCT03563222?
The interventions under investigation include: Smoflipid (DRUG), Intralipid, 20% (DRUG).
Who is sponsoring clinical trial NCT03563222?
This trial is sponsored by Fresenius Kabi, which has 4 total clinical trials registered on ClinicalTrials.gov.
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