Trial Outcomes & Findings for Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI) (NCT NCT01201759)
NCT ID: NCT01201759
Last Updated: 2015-06-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
Results posted on
2015-06-10
Participant Flow
Participants underwent randomization to either 1 month of Salsalate ( 4.0 grams daily in split doses) or placebo.
An untreated wash-in (1 month) preceded treatment (1 month).A 1 month wash-out between cross-over.
Participant milestones
| Measure |
Placebo to Salsalate 2gr BID
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 to Placebo 2gr BID
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
|
|---|---|---|
|
Visit 1 Wash-in ( Untreated)
STARTED
|
10
|
8
|
|
Visit 1 Wash-in ( Untreated)
COMPLETED
|
8
|
7
|
|
Visit 1 Wash-in ( Untreated)
NOT COMPLETED
|
2
|
1
|
|
Visit 2
STARTED
|
8
|
7
|
|
Visit 2
COMPLETED
|
8
|
7
|
|
Visit 2
NOT COMPLETED
|
0
|
0
|
|
Visit 3 - Washout
STARTED
|
8
|
7
|
|
Visit 3 - Washout
COMPLETED
|
7
|
4
|
|
Visit 3 - Washout
NOT COMPLETED
|
1
|
3
|
|
Visit 4 Crossover
STARTED
|
7
|
4
|
|
Visit 4 Crossover
COMPLETED
|
7
|
3
|
|
Visit 4 Crossover
NOT COMPLETED
|
0
|
1
|
|
Visit 5
STARTED
|
7
|
3
|
|
Visit 5
COMPLETED
|
7
|
3
|
|
Visit 5
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo to Salsalate 2gr BID
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 to Placebo 2gr BID
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
|
|---|---|---|
|
Visit 1 Wash-in ( Untreated)
Lost to Follow-up
|
2
|
1
|
|
Visit 3 - Washout
Adverse Event
|
0
|
3
|
|
Visit 3 - Washout
Lost to Follow-up
|
1
|
0
|
|
Visit 4 Crossover
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)
Baseline characteristics by cohort
| Measure |
Placebo to Salsalate 2gr BID
n=10 Participants
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 to Placebo 2gr BID
n=8 Participants
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
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 10 • n=99 Participants
|
25 years
STANDARD_DEVIATION 3 • n=107 Participants
|
33 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..Population: All enrolled participants who completed the study.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Salsalate
n=10 Participants
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
|
|---|---|---|
|
Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
|
-34 mg*min/dL
Standard Deviation 104
|
-62 mg*min/dL
Standard Deviation 136
|
SECONDARY outcome
Timeframe: Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..Population: All participants who completed treatment.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Salsalate
n=10 Participants
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
|
|---|---|---|
|
Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
|
1 mg*min/dL
Standard Deviation 15
|
-8 mg*min/dL
Standard Deviation 20
|
SECONDARY outcome
Timeframe: Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..Population: All enrolled participants who completed the study.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Salsalate
n=10 Participants
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
|
|---|---|---|
|
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.
|
8 mg*min/dL
Standard Deviation 193
|
-111 mg*min/dL
Standard Deviation 174
|
SECONDARY outcome
Timeframe: Study visit at min -30 (fasting)Population: All enrolled participants who completed the study.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Salsalate
n=10 Participants
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
|
|---|---|---|
|
Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
Pre-Intervention
|
0.48 mg/dL
Standard Deviation 0.35
|
0.51 mg/dL
Standard Deviation 0.55
|
|
Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
Post-Intervention
|
0.50 mg/dL
Standard Deviation 0.49
|
0.19 mg/dL
Standard Deviation 0.53
|
Adverse Events
Placebo 2gr BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Salsalate 2gr BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo 2gr BID
n=18 participants at risk
Placebo twice a day for 30 days.
|
Salsalate 2gr BID
n=18 participants at risk
Salsalate 2grams twice a day for 30 days.
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/18 • Intervention period (30 days Placebo/Salsalate) .
Population included all participants who received at least one dose of the intervention Placebo or Salsalate.
|
11.1%
2/18 • Number of events 2 • Intervention period (30 days Placebo/Salsalate) .
Population included all participants who received at least one dose of the intervention Placebo or Salsalate.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/18 • Intervention period (30 days Placebo/Salsalate) .
Population included all participants who received at least one dose of the intervention Placebo or Salsalate.
|
5.6%
1/18 • Number of events 1 • Intervention period (30 days Placebo/Salsalate) .
Population included all participants who received at least one dose of the intervention Placebo or Salsalate.
|
|
Gastrointestinal disorders
Abdominal Bloating
|
0.00%
0/18 • Intervention period (30 days Placebo/Salsalate) .
Population included all participants who received at least one dose of the intervention Placebo or Salsalate.
|
5.6%
1/18 • Number of events 1 • Intervention period (30 days Placebo/Salsalate) .
Population included all participants who received at least one dose of the intervention Placebo or Salsalate.
|
Additional Information
Dr. Mark S. Nash
UNIVERSITY OF MIAMI- The Miami Project to Cure Paralysis
Phone: (305) 243-3628
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place