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Trial record 38 of 7493 for:    Area Under Curve

Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)

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ClinicalTrials.gov Identifier: NCT01201759
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Spinal Cord Injury
Interventions Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days
Drug: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
Enrollment 18
Recruitment Details Participants underwent randomization to either 1 month of Salsalate ( 4.0 grams daily in split doses) or placebo.
Pre-assignment Details An untreated wash-in (1 month) preceded treatment (1 month).A 1 month wash-out between cross-over.
Arm/Group Title Placebo to Salsalate 2gr BID Salsalate to Placebo 2gr BID
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Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.

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

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

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

Period Title: Visit 1 Wash-in ( Untreated)
Started 10 8
Completed 8 7
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Period Title: Visit 2
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Visit 3 - Washout
Started 8 7
Completed 7 4
Not Completed 1 3
Reason Not Completed
Adverse Event             0             3
Lost to Follow-up             1             0
Period Title: Visit 4 Crossover
Started 7 4
Completed 7 3
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Period Title: Visit 5
Started 7 3
Completed 7 3
Not Completed 0 0
Arm/Group Title Placebo to Salsalate 2gr BID Salsalate to Placebo 2gr BID Total
Hide Arm/Group Description

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

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 10 8 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
8
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 8 participants 18 participants
36  (10) 25  (3) 33  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
8
 100.0%
18
 100.0%
1.Primary Outcome
Title Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
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The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min.

For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors.

Time Frame Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who completed the study.
Arm/Group Title Placebo Salsalate
Hide Arm/Group Description:
Placebo 2 grams twice a day for 30 days. 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.
Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days 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
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mg*min/dL
-34  (104) -62  (136)
2.Secondary Outcome
Title Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Hide Description

The postprandial glycemia is assessed by the change in the AUC for plasma glucose sampled before and after intervention at time points of 0 (immediately post-feeding) to 480 min.

For peak Glucose, and Glucose area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors.

Time Frame Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed treatment.
Arm/Group Title Placebo Salsalate
Hide Arm/Group Description:
Placebo 2 grams twice a day for 30 days. 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.
Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days 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
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mg*min/dL
1  (15) -8  (20)
3.Secondary Outcome
Title Change in Area Under the Curve (AUC) for Lipemia (Free Fatty Acids ) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Hide Description

The postprandial lipemia is assessed by the change in the AUC for plasma Free fatty acids (FFA)sampled before and after intervention at time points of 0min immediately post feeding to 480 min.

For peak FFA area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors.

Time Frame Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who completed the study.
Arm/Group Title Placebo Salsalate
Hide Arm/Group Description:
Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: 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.
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: 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
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mg*min/dL
8  (193) -111  (174)
4.Secondary Outcome
Title Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
Hide Description

The pro-atherogenic inflammatory mediators are assessed by the change in fasting values of Interleukin-6 in plasma concentration Pre and Post intervention at -30 min ( fasting).

For fasting values treatments (placebo and salsalate) and visits (pre and post) were defined as within subject’s factors.

Time Frame Study visit at min -30 (fasting)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who completed the study.
Arm/Group Title Placebo Salsalate
Hide Arm/Group Description:
Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: 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.
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: 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
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
Pre-Intervention 0.48  (0.35) 0.51  (0.55)
Post-Intervention 0.50  (0.49) 0.19  (0.53)
Time Frame Intervention period (30 days Placebo/Salsalate) .
Adverse Event Reporting Description Population included all participants who received at least one dose of the intervention Placebo or Salsalate.
 
Arm/Group Title Placebo 2gr BID Salsalate 2gr BID
Hide Arm/Group Description Placebo twice a day for 30 days. Salsalate 2grams twice a day for 30 days.
All-Cause Mortality
Placebo 2gr BID Salsalate 2gr BID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 2gr BID Salsalate 2gr BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 2gr BID Salsalate 2gr BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      3/18 (16.67%)    
Ear and labyrinth disorders     
Tinnitus *  0/18 (0.00%)  0 1/18 (5.56%)  1
Gastrointestinal disorders     
Abdominal Bloating *  0/18 (0.00%)  0 1/18 (5.56%)  1
General disorders     
Fatigue *  0/18 (0.00%)  0 2/18 (11.11%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark S. Nash
Organization: UNIVERSITY OF MIAMI- The Miami Project to Cure Paralysis
Phone: (305) 243-3628
EMail: MNash@med.miami.edu
Layout table for additonal information
Responsible Party: Mark S. Nash, Ph.D., FACSM, University of Miami
ClinicalTrials.gov Identifier: NCT01201759     History of Changes
Other Study ID Numbers: 20090361
TMP-MN-004 ( Other Identifier: Clinicaltrials.gov )
First Submitted: September 8, 2010
First Posted: September 15, 2010
Results First Submitted: January 28, 2015
Results First Posted: June 10, 2015
Last Update Posted: June 10, 2015