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NCT02579265 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
A Phase 3 study, sponsored by Fresenius Kabi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 204
- Enrollment target
NCT02579265 is a Phase 3 study that was terminated before completion, run by Fresenius Kabi. The registered enrollment target is 204 participants.
The verdict
NCT02579265, a Phase 3 study, was terminated before completion, sponsored by Fresenius Kabi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 204 participants
- Enrollment target
Study Summary
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.
Interventions
- DRUG Smoflipid 20% (investigational lipid for parenteral nutrition)
- DRUG Intralipid® 20%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2015-12 |
| Est. Completion | 2020-04-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02579265
The ClinicalTrials.gov registry entry for NCT02579265 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 204 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 20% (investigational lipid for parenteral nutrition) is the first listed.
NCT02579265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02579265 about?
NCT02579265 is a clinical study titled "Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants". To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.
What is the current status of trial NCT02579265?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 204 participants. The study started on 2015-12. Estimated completion is 2020-04-10.
What interventions are being tested in trial NCT02579265?
The interventions under investigation include: Smoflipid 20% (investigational lipid for parenteral nutrition) (DRUG), Intralipid® 20% (DRUG).
Who is sponsoring clinical trial NCT02579265?
This trial is sponsored by Fresenius Kabi, which has 4 total clinical trials registered on ClinicalTrials.gov.
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