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Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02338999
Recruitment Status : Completed
First Posted : January 15, 2015
Results First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Systemic Lupus Erythematosus
Interventions Radiation: PET/CT
Drug: Pioglitazone
Drug: Placebo
Enrollment 88
Recruitment Details  
Pre-assignment Details 88 subjects were consented; 5 subjects declined participation after consent and 3 subjects did not meet eligibility criteria.
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description Treatment with pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for three months. Followed by a two-month washout period before cross over to placebo treatment for 3 months. Treatment with placebo for 3 months. Followed by a 2-month washout period before cross over to pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for an additional 3 months.
Period Title: First Intervention
Started 39 41
Completed 36 40
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             3             1
Period Title: Washout Period
Started 36 40
Completed 36 38
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Period Title: Second Intervention
Started 36 38
Completed 36 36
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone Total
Hide Arm/Group Description Treatment with pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for three months. Followed by a two-month washout period before cross over to placebo treatment for 3 months. Treatment with placebo for 3 months. Followed by a 2-month washout period before cross over to pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for an additional 3 months. Total of all reporting groups
Overall Number of Baseline Participants 39 41 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
  84.6%
39
  95.1%
72
  90.0%
>=65 years
6
  15.4%
2
   4.9%
8
  10.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 80 participants
Female
33
  84.6%
37
  90.2%
70
  87.5%
Male
6
  15.4%
4
   9.8%
10
  12.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 80 participants
Hispanic or Latino
16
  41.0%
17
  41.5%
33
  41.3%
Not Hispanic or Latino
22
  56.4%
24
  58.5%
46
  57.5%
Unknown or Not Reported
1
   2.6%
0
   0.0%
1
   1.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
  10.3%
5
  12.2%
9
  11.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  23.1%
10
  24.4%
19
  23.8%
White
17
  43.6%
17
  41.5%
34
  42.5%
More than one race
1
   2.6%
1
   2.4%
2
   2.5%
Unknown or Not Reported
8
  20.5%
8
  19.5%
16
  20.0%
1.Primary Outcome
Title Change in Vascular Function and Cardiometabolic Risk as Measured by Left CAVI at Month 3
Hide Description

Change in vascular function using non-invasive vascular tests, measuring vascular compliance - Cardio ankle vascular index (CAVI).

CAVI is an index reflecting the stiffness of the artery from the heart to ankles; it increases with atherosclerosis progression. CAVI was measured using VaSera-1500A (Fukuda Denshi Co. Redmond, WA)

Time Frame 3 months after start of first intervention (Baseline to 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only subjects who completed all visits
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description:
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Overall Number of Participants Analyzed 39 41
Mean (Standard Deviation)
Unit of Measure: unitless
-0.32  (0.96) 0.09  (0.68)
2.Primary Outcome
Title Change in Vascular Function and Cardiometabolic Risk as Measured by Left CAVI at Month 8
Hide Description

Change in vascular function using non-invasive vascular tests, measuring vascular compliance - Cardio ankle vascular index (CAVI).

CAVI is an index reflecting the stiffness of the artery from the heart to ankles; it increases with atherosclerosis progression. CAVI was measured using VaSera-1500A (Fukuda Denshi Co. Redmond, WA)

Time Frame 3 months after start of second intervention (5 months to 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only subjects who completed all visits
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description:
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: unitless
-0.29  (0.55) -0.07  (0.63)
3.Primary Outcome
Title Change in Vascular Function and Cardiometabolic Risk as Measured by Right CAVI at Month 3
Hide Description

Change in vascular function using non-invasive vascular tests, measuring vascular compliance - Cardio ankle vascular index (CAVI).

CAVI is an index reflecting the stiffness of the artery from the heart to ankles; it increases with atherosclerosis progression. CAVI was measured using VaSera-1500A (Fukuda Denshi Co. Redmond, WA)

Time Frame 3 months after start of first intervention (Baseline to 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only subjects who completed all visits
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description:
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Overall Number of Participants Analyzed 39 41
Mean (Standard Deviation)
Unit of Measure: unitless
-0.42  (0.88) 0.12  (0.65)
4.Primary Outcome
Title Change in Vascular Function and Cardiometabolic Risk as Measured by Right CAVI at Month 8
Hide Description

Change in vascular function using non-invasive vascular tests, measuring vascular compliance - Cardio ankle vascular index (CAVI).

CAVI is an index reflecting the stiffness of the artery from the heart to ankles; it increases with atherosclerosis progression. CAVI was measured using VaSera-1500A (Fukuda Denshi Co. Redmond, WA)

Time Frame 3 months after start of second intervention (5 months to 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only subjects who completed all visits
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description:
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: unitless
-0.26  (0.61) -0.08  (0.71)
5.Primary Outcome
Title Change in Vascular Function and Cardiometabolic Risk as Measured by PWV at Month 3
Hide Description

Change in vascular function using non-invasive vascular tests, measuring vascular compliance -Pulse, wave, velocity (PWV).

The central aortic pressure PWV was determined by using the pressure tonometer and an EKG signal was used simultaneously to visualize ventricular-vascular interactions. It increases with atherosclerosis progression. Central aortic BP and stiffness were quantified using SphygmoCor CP system (AtCor Medical Pty Ltd.; New South Wales, Australia).

Time Frame 3 months after start of first intervention (Baseline to 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only subjects who completed all visits
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description:
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Overall Number of Participants Analyzed 39 41
Mean (Standard Deviation)
Unit of Measure: m/s
-0.31  (2.06) 0.03  (2.03)
6.Primary Outcome
Title Change in Vascular Function and Cardiometabolic Risk as Measured by PWV at Month 8
Hide Description

Change in vascular function using non-invasive vascular tests, measuring vascular compliance -Pulse, wave, velocity (PWV).

The central aortic pressure PWV was determined by using the pressure tonometer and an EKG signal was used simultaneously to visualize ventricular-vascular interactions. It increases with atherosclerosis progression. Central aortic BP and stiffness were quantified using SphygmoCor CP system (AtCor Medical Pty Ltd.; New South Wales, Australia).

Time Frame 3 months after start of second intervention (5 months to 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only subjects who completed all visits
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description:
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: m/s
-0.31  (1.86) -0.25  (0.94)
7.Primary Outcome
Title Change in Vascular Function and Cardiometabolic Risk as Measured by RHI at Month 3
Hide Description

Change in vascular function using non-invasive vascular tests, measuring vascular compliance -Reactive hyperemia index (RHI).

RHI is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. The possible range of scores is 1 to 3. Increasing score indicates the improvement of coronary endothelial function

Time Frame 3 months after start of first intervention (Baseline to 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only subjects who completed all visits
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description:
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Overall Number of Participants Analyzed 39 41
Mean (Standard Deviation)
Unit of Measure: ratio
0.07  (0.35) 0.02  (0.48)
8.Primary Outcome
Title Change in Vascular Function and Cardiometabolic Risk as Measured by RHI at Month 8
Hide Description

Change in vascular function using non-invasive vascular tests, measuring vascular compliance -Reactive hyperemia index (RHI).

RHI is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. The possible range of scores is 1 to 3. Increasing score indicates the improvement of coronary endothelial function

Time Frame 3 months after start of second intervention (5 months to 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only subjects who completed all visits
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description:
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: ratio
-0.05  (0.35) 0.02  (0.36)
9.Primary Outcome
Title Effect of Pioglitazone on Vascular Inflammation and Cardiometabolic Risk as Measured by TBR Value at Month 3
Hide Description Change in vascular inflammation using non-invasive vascular test, measuring changes in target to blood pool ratio (TBR) value by positron emission tomography (PET) computerized tomography (CT). The higher the value, the higher the degree of vascular inflammation.
Time Frame 3 months after start of first intervention (Baseline to 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only subjects who completed all visits
Arm/Group Title Pioglitazone, Then Placebo Placebo, Then Pioglitazone
Hide Arm/Group Description:
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: ratio
0.0337  (0.1991) 0.0351  (0.2954)
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description Treatment with pioglitazone up to 45 mg orally daily for three months. Treatment with placebo orally daily for 3 months.
All-Cause Mortality
Pioglitazone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)      0/77 (0.00%)    
Hide Serious Adverse Events
Pioglitazone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/77 (1.30%)      5/77 (6.49%)    
Endocrine disorders     
Thyroid mass   1/77 (1.30%)  1 0/77 (0.00%)  0
Infections and infestations     
Enterocolitis infectious   0/77 (0.00%)  0 2/77 (2.60%)  2
Sepsis   0/77 (0.00%)  1/77 (1.30%)  1
Musculoskeletal and connective tissue disorders     
Limb mass   0/77 (0.00%)  1/77 (1.30%)  1
Vascular disorders     
Peripheral ischaemia   0/77 (0.00%)  1/77 (1.30%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pioglitazone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/77 (42.86%)      33/77 (42.86%)    
Blood and lymphatic system disorders     
Anaemia   3/77 (3.90%)  3 1/77 (1.30%)  1
Leukopenia   1/77 (1.30%)  1 0/77 (0.00%) 
Lymphadenopathy   1/77 (1.30%)  1 0/77 (0.00%) 
Cardiac disorders     
Osler's nodes   0/77 (0.00%)  1/77 (1.30%)  1
Tachycardia   0/77 (0.00%)  1/77 (1.30%)  1
Eye disorders     
Dry eye   0/77 (0.00%)  1/77 (1.30%)  1
Episcleritis   1/77 (1.30%)  1 0/77 (0.00%) 
Lacrimation increased   1/77 (1.30%)  1 0/77 (0.00%) 
Vision blurred   0/77 (0.00%)  1/77 (1.30%)  1
Gastrointestinal disorders     
Abdominal distension   3/77 (3.90%)  3 2/77 (2.60%)  2
Abdominal pain   1/77 (1.30%)  1 0/77 (0.00%) 
Constipation   1/77 (1.30%)  1 1/77 (1.30%)  1
Diarrhoea   1/77 (1.30%)  1 1/77 (1.30%)  1
Dry mouth   0/77 (0.00%)  1/77 (1.30%)  1
Dyspepsia   2/77 (2.60%)  2 0/77 (0.00%) 
Dysphagia   1/77 (1.30%)  1 0/77 (0.00%) 
Enterovesical fistula   0/77 (0.00%)  1/77 (1.30%)  1
Frequent bowel movements   1/77 (1.30%)  1 0/77 (0.00%) 
Gastritis   2/77 (2.60%)  2 0/77 (0.00%) 
Gastrooesophageal reflux disease   1/77 (1.30%)  1 2/77 (2.60%)  2
Nausea   4/77 (5.19%)  4 4/77 (5.19%)  4
Oral pain   0/77 (0.00%)  1/77 (1.30%)  1
Vomiting   1/77 (1.30%)  1 0/77 (0.00%) 
General disorders     
Administration site pain   0/77 (0.00%)  1/77 (1.30%)  1
Fatigue   5/77 (6.49%)  5 1/77 (1.30%)  1
Feeling cold   0/77 (0.00%)  1/77 (1.30%)  1
Influenza like illness   1/77 (1.30%)  1 0/77 (0.00%) 
Localised oedema   1/77 (1.30%)  1 1/77 (1.30%)  1
Non-cardiac chest pain   0/77 (0.00%)  2/77 (2.60%)  2
Oedema peripheral   1/77 (1.30%)  1 1/77 (1.30%)  1
Pain   0/77 (0.00%)  1/77 (1.30%)  1
Peripheral swelling   0/77 (0.00%)  1/77 (1.30%)  1
Infections and infestations     
Gastritis viral   1/77 (1.30%)  1 2/77 (2.60%)  2
Gastrointestinal viral infection   0/77 (0.00%)  1/77 (1.30%)  1
Herpes zoster   1/77 (1.30%)  1 0/77 (0.00%) 
Influenza   0/77 (0.00%)  1/77 (1.30%)  1
Sinusitis   1/77 (1.30%)  1 1/77 (1.30%)  1
Tooth infection   0/77 (0.00%)  1/77 (1.30%)  2
Upper respiratory tract infection   7/77 (9.09%)  8 10/77 (12.99%)  11
Urinary tract infection   1/77 (1.30%)  1 9/77 (11.69%)  10
Vaginal infection   1/77 (1.30%)  1 1/77 (1.30%)  1
Viral upper respiratory tract infection   3/77 (3.90%)  3 2/77 (2.60%)  2
Injury, poisoning and procedural complications     
Arthropod bite   1/77 (1.30%)  1 0/77 (0.00%) 
Exposure to allergen   0/77 (0.00%)  1/77 (1.30%)  1
Fall   1/77 (1.30%)  1 0/77 (0.00%) 
Investigations     
Alanine aminotransferase increased   5/77 (6.49%)  5 0/77 (0.00%) 
Aspartate aminotransferase increased   2/77 (2.60%)  3 3/77 (3.90%)  3
Biopsy lymph gland   1/77 (1.30%)  1 0/77 (0.00%) 
Blood bicarbonate decreased   1/77 (1.30%)  2 0/77 (0.00%) 
Blood creatinine increased   1/77 (1.30%)  1 1/77 (1.30%)  1
Blood urea increased   0/77 (0.00%)  1/77 (1.30%)  1
Cardiac murmur   3/77 (3.90%)  3 0/77 (0.00%) 
Computerised tomogram abnormal   1/77 (1.30%)  1 0/77 (0.00%) 
Computerised tomogram coronary artery abnormal   1/77 (1.30%)  1 0/77 (0.00%) 
Helicobacter test positive   1/77 (1.30%)  1 0/77 (0.00%) 
International normalised ratio increased   0/77 (0.00%)  1/77 (1.30%)  1
Lymphocyte count decreased   1/77 (1.30%)  1 1/77 (1.30%)  1
Neutrophil count decreased   1/77 (1.30%)  2 1/77 (1.30%)  2
Platelet count decreased   2/77 (2.60%)  2 2/77 (2.60%)  2
Weight decreased   1/77 (1.30%)  1 0/77 (0.00%) 
Weight increased   3/77 (3.90%)  3 0/77 (0.00%) 
White blood cell count decreased   7/77 (9.09%)  8 1/77 (1.30%)  1
Metabolism and nutrition disorders     
Anorexia nervosa   1/77 (1.30%)  1 0/77 (0.00%) 
Decreased appetite   1/77 (1.30%)  1 0/77 (0.00%) 
Hypertriglyceridaemia   1/77 (1.30%)  1 1/77 (1.30%)  1
Hypokalaemia   0/77 (0.00%)  1/77 (1.30%)  1
Increased appetite   1/77 (1.30%)  1 1/77 (1.30%)  1
Musculoskeletal and connective tissue disorders     
Back pain   0/77 (0.00%)  1/77 (1.30%)  1
Chills   1/77 (1.30%)  1 0/77 (0.00%) 
Muscle spasms   1/77 (1.30%)  1 0/77 (0.00%) 
Muscular weakness   0/77 (0.00%)  1/77 (1.30%)  1
Myalgia   1/77 (1.30%)  1 1/77 (1.30%)  1
Pain in extremity   4/77 (5.19%)  4 1/77 (1.30%)  1
Nervous system disorders     
Disturbance in attention   1/77 (1.30%)  1 0/77 (0.00%) 
Dizziness   4/77 (5.19%)  5 7/77 (9.09%)  7
Headache   2/77 (2.60%)  2 7/77 (9.09%)  8
Memory impairment   1/77 (1.30%)  1 0/77 (0.00%) 
Numbness   1/77 (1.30%)  1 0/77 (0.00%) 
Paraesthesia   2/77 (2.60%)  3 0/77 (0.00%) 
Presyncope   0/77 (0.00%)  1/77 (1.30%)  1
Somnolence   2/77 (2.60%)  2 3/77 (3.90%)  3
Psychiatric disorders     
Depression   0/77 (0.00%)  1/77 (1.30%)  1
Insomnia   1/77 (1.30%)  1 1/77 (1.30%)  1
Panic attack   1/77 (1.30%)  1 0/77 (0.00%) 
Renal and urinary disorders     
Cystitis   0/77 (0.00%)  1/77 (1.30%)  1
Dysuria   3/77 (3.90%)  3 0/77 (0.00%) 
Fluid retention   1/77 (1.30%)  1 0/77 (0.00%) 
Micturition disorder   2/77 (2.60%)  2 0/77 (0.00%) 
Nocturia   0/77 (0.00%)  1/77 (1.30%)  1
Reproductive system and breast disorders     
Breast pain   0/77 (0.00%)  1/77 (1.30%)  1
Galactorrhoea   1/77 (1.30%)  1 0/77 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough   1/77 (1.30%)  2 2/77 (2.60%)  2
Dyspnoea   2/77 (2.60%)  2 2/77 (2.60%)  2
Laryngeal inflammation   1/77 (1.30%)  1 2/77 (2.60%)  2
Pharyngitis   1/77 (1.30%)  1 1/77 (1.30%)  1
Productive Cough   0/77 (0.00%)  1/77 (1.30%)  1
Rhinitis allergic   2/77 (2.60%)  2 0/77 (0.00%) 
Upper-airway cough syndrome   0/77 (0.00%)  1/77 (1.30%)  1
Wheezing   2/77 (2.60%)  2 0/77 (0.00%) 
Skin and subcutaneous tissue disorders     
Pain of Skin   1/77 (1.30%)  1 0/77 (0.00%) 
Pruritus   1/77 (1.30%)  1 1/77 (1.30%)  1
Rash macular   0/77 (0.00%)  1/77 (1.30%)  1
Vascular disorders     
Hot flush   1/77 (1.30%)  1 0/77 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Kaplan, Mariana
Organization: National Inst of Arthritis and Musculoskeletal and Skin Diseases
Phone: +1 301 496 0517
EMail: mariana.kaplan@nih.gov
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Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )
ClinicalTrials.gov Identifier: NCT02338999    
Other Study ID Numbers: 150060
15-AR-0060
First Submitted: January 14, 2015
First Posted: January 15, 2015
Results First Submitted: July 12, 2021
Results First Posted: September 14, 2021
Last Update Posted: September 14, 2021