CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
SPM Emulsion, Dose-modality +2 moredietary
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/NCT02719665
NCT02719665N/ACompleted
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THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease

University of California, San Francisco·interventional·Posted Mar 25, 2016·Updated May 7, 2021

In Brief

A clinical study evaluating SPM Emulsion, Dose-modality, SPM Softgel, Dose-Modality, and 1 other intervention for Peripheral Arterial Disease and 6 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion."

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease, Claudication, Claudication, Intermittent, Vascular Occlusion, Vascular Calcification, Vascular Diseases, Osteoarthritis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 25, 2016
Enrollment StartMar 1, 2016
Primary CompletionDec 15, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.3 years ago

Interventions

SPM Emulsion, Dose-modalitydietary

Phase 1a Dose-Finding oral SPM administration of increasing dose (15ml, 30ml, and 60ml) by the following schedule: Days 1 to 5: 15 ml; Days 6 to 14: Washout, no SPM administration; Days 15 to 19: 30 ml; Days 20-28: Washout, no SPM administration; Days 29-33: 60 ml

SPM Softgel, Dose-Modalitydietary

Phase 1b Dose-Finding oral softtel SPM administration of two different doses (2 softgel vs 4 softgel) Days 0 to 5: 2 SPM softgel; Days 6 to 21: Washout, no SPM administration; Days 22 to 26: 4 SPM softgel; Days 27-42: Washout, no SPM administration

Placebo Softgeldietary

Days 43-47: 4 Placebo softgel; Day 48-64 Washout