Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
- Conditions
- Raynaud's Disease
- Registration Number
- NCT00266669
- Lead Sponsor
- MediQuest Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Clinical diagnosis of Raynaud's phenomenon
- 2 or more Raynaud's events on a typical winter day
- Agree to discontinue current treatments for Raynaud's
- Negative pregnancy test and agree to use effective contraception during study
- Current use of nitrate medications or medications known to interact with nitroglycerin
- Patients who currently use medications, like calcium channel blockers, that might interfere with study medication
- Patients with a known allergy to nitroglycerin or common topical ingredients
- Patients with a history of migraine headaches
- Patients with a history of unstable medical problems
- Patients with cognitive or language difficulties that would impair completion of assessment instruments
- Patients with lab screening values more than 20% outside normal range
- Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening
- Pregnant or nursing women
- Women of child-bearing potential who are unwilling to comply with the contraceptive requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (19)
University of Medicine and Dentistry of New Jersey
🇺🇸New Brunswick, New Jersey, United States
University of Chicago Center for Advanced Medicine
🇺🇸Chicago, Illinois, United States
The Center for Rheumatology
🇺🇸Albany, New York, United States
SUNY Stony Brook
🇺🇸East Setauket, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Colorado at Denver and Health Sciences Center
🇺🇸Denver, Colorado, United States
University of Connecticut
🇺🇸Farmington, Connecticut, United States
Stanford Medical School
🇺🇸Stanford, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
St. Joseph's Health Care
🇨🇦London, Ontario, Canada
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
Arthritis Education & Treatment Center, PLLC
🇺🇸Grand Rapids, Michigan, United States
Virginia Mason Benaroya Research Institute
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
SMBD Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Texas Medical School at Houston
🇺🇸Houston, Texas, United States
Medical University of Ohio
🇺🇸Toledo, Ohio, United States