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Sponsored by: |
MediQuest Therapeutics |
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Information provided by: | MediQuest Therapeutics |
ClinicalTrials.gov Identifier: | NCT00577304 |
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.
Condition | Intervention | Phase |
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Raynaud's Disease Raynaud's Disease Secondary to Scleroderma Raynaud's Disease Secondary to Other Autoimmune Disease |
Drug: Nitroglycerin Drug: Topical AmphiMatrix |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon |
Estimated Enrollment: | 200 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2
Placebo - Topical AmphiMatrix
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Drug: Topical AmphiMatrix
Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
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1: Active Comparator
Topical AmphiMatrix with Nitroglycerin
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Drug: Nitroglycerin
Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix with Nitroglycerin. Each dose contains 4.5mg of Nitroglycerin. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
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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.
Ages Eligible for Study: | 15 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80045 | |
United States, Connecticut | |
University of Connecticut | |
Farmington, Connecticut, United States, 06030 | |
United States, District of Columbia | |
Georgetown University | |
Washington, District of Columbia, United States, 20007 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21224 | |
United States, Massachusetts | |
Boston University | |
Boston, Massachusetts, United States, 02118 | |
United States, Michigan | |
Arthritis Education and Treatment Center, PLLC | |
Grand Rapids, Michigan, United States, 49546 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey | |
New Brunswick, New Jersey, United States, 08093 | |
United States, New York | |
SUNY Stony Brook | |
Stony Brook, New York, United States, 11794 | |
The Center for Rheumatology | |
Albany, New York, United States, 12206 | |
United States, North Carolina | |
Carolina Arthritis | |
Wilmington, North Carolina, United States, 28401 | |
United States, Ohio | |
University of Toledo | |
Toledo, Ohio, United States, 43614 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
University of Texas at Houston | |
Houston, Texas, United States, 77030 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Study Director: | Jan Ohrstrom, PhD | MediQuest Therapeutics |
Responsible Party: | MediQuest Therapeutics, Inc. ( Fred Dechow/President and CEO ) |
Study ID Numbers: | 07-005 |
Study First Received: | December 18, 2007 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00577304 |
Health Authority: | United States: Food and Drug Administration |
Raynaud's Nitroglycerin Scleroderma |
Nitroglycerin Peripheral Vascular Diseases Autoimmune Diseases |
Raynaud Disease Vascular Diseases Neoplasm Metastasis |
Vasodilator Agents Neoplasms Neoplastic Processes Pathologic Processes Immune System Diseases |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |