A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
This trial is active, not recruiting.
|Conditions||raynaud's disease, raynaud's disease secondary to scleroderma, raynaud's disease secondary to other autoimmune disease|
|Treatments||nitroglycerin, topical amphimatrix|
|Start date||December 2007|
|End date||March 2008|
|Trial size||200 participants|
|Trial identifier||NCT00577304, 07-005|
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase blood flow to the fingers.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Stanford, CA||Stanford University||no longer recruiting|
|Denver, CO||University of Colorado Health Sciences Center||no longer recruiting|
|Farmington, CT||University of Connecticut||no longer recruiting|
|Washington, DC||Georgetown University||no longer recruiting|
|Chicago, IL||University of Chicago||no longer recruiting|
|Baltimore, MD||Johns Hopkins University||no longer recruiting|
|Boston, MA||Boston University||no longer recruiting|
|Grand Rapids, MI||Arthritis Education and Treatment Center, PLLC||no longer recruiting|
|Minneapolis, MN||University of Minnesota||no longer recruiting|
|New Brunswick, NJ||University of Medicine and Dentistry of New Jersey||no longer recruiting|
|Albany, NY||The Center for Rheumatology||no longer recruiting|
|Stony Brook, NY||SUNY Stony Brook||no longer recruiting|
|Wilmington, NC||Carolina Arthritis||no longer recruiting|
|Toledo, OH||University of Toledo||no longer recruiting|
|Charleston, SC||Medical University of South Carolina||no longer recruiting|
|Houston, TX||University of Texas at Houston||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Reduction in Raynaud's Condition Score
time frame: three months
Frequency and severity of adverse events.
time frame: three months
Male or female participants from 15 years up to 70 years old.
Inclusion Criteria: - Outpatients ages 15 - 70. - Patients with a diagnosis of Raynaud's phenomenon. - Patients who agree to apply study medication to their fingers. - Patients who are willing to stop current topical vasodilator therapies. - Patients who agree not to start or change dosage of current oral vasodilator therapies. - Patients who agree not to use any nitrate therapy while participating in this study. - Negative pregnancy test in fertile women and agreement to use effective contraception throughout the study. Exclusion Criteria: - Patients who currently use nitrate medication or medications known to interact with nitroglycerin. - Patients who have an allergy to nitroglycerin or common topical gel ingredients. - Patients with a history of severe headaches. - Patients with an unstable medical problem. - Patients with cognitive or language difficulties that would impair their ability to complete assessment of pain instruments. - Patients who have had a recent heart attack or other uncontrolled heart condition. - Patients who have participated in an investigational drug study within four weeks of visit one. - Patients who have clinically significant abnormal lab values. - Patients who have had recent major abdominal, thoracic or vascular surgery. - Patients with interfering skin conditions. - Pregnant or nursing women or women unwilling to comply with contraceptive requirements.
|Official title||A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon|
|Description||The purpose of this clinical study is to determine, in a controlled fashion, the ability of a topical formulation of Nitroglycerin, MQX-503, to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's Phenomenon (RP) and with moderate to severe Raynaud's Phenomenon secondary to autoimmune diseases, such as scleroderma.|
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