CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days +1 moredrug
Likely dose
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days 4.0 gfrom 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.

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NCT01201759N/ACompleted
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Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI

University of Miami·interventional·Posted Sep 15, 2010·Updated Jun 10, 2015

In Brief

A clinical study evaluating Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days and Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days. for Spinal Cord Injury. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The overall study objectives are to examine whether: 1. Persons with spinal cord injury (SCI) having elevated body mass are at greater cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with SCI having 'normal' body mass, and 2. An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injury
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2010
Enrollment StartJul 1, 2009
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.8 years ago

Interventions

Salsalate 2grams twice a day for 30 days. Then Placebo for 30 daysdrug

Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2

Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.drug

Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.