The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Stanford Medical School
Stanford, California, United States
University of Colorado at Denver and Health Sciences Center
Improvements in Raynaud's Assessment Score comparing active to placebo
Reduction of number of Raynaud's events
Decrease in duration of Raynaud's events
Decrease in symptoms associated with Raynaud's
Assess safety: frequency and severity of adverse events associated with the study drug
Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
Reduction in emergence of digital ulcers for patients with scleroderma
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Denver, Colorado, United States
University of Connecticut
Farmington, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Center for Advanced Medicine
Chicago, Illinois, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Arthritis Education & Treatment Center, PLLC
Grand Rapids, Michigan, United States
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States
The Center for Rheumatology
Albany, New York, United States
...and 9 more locations