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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Other | Placebo - Topical AmphiMatrix |
|
| 1 | Active Comparator | Topical AmphiMatrix with Nitroglycerin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Raynaud's Condition Score | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events. | three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Ohrstrom, PhD | MediQuest Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| University of Colorado Health Sciences Center |
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| Label | URL |
|---|---|
| Sponsor web site | View source |
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|
| Topical AmphiMatrix | Drug | 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. |
|
| Denver |
| Colorado |
| 80045 |
| United States |
| University of Connecticut | Farmington | Connecticut | 06030 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| Boston University | Boston | Massachusetts | 02118 | United States |
| Arthritis Education and Treatment Center, PLLC | Grand Rapids | Michigan | 49546 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Medicine and Dentistry of New Jersey | New Brunswick | New Jersey | 08093 | United States |
| The Center for Rheumatology | Albany | New York | 12206 | United States |
| SUNY Stony Brook | Stony Brook | New York | 11794 | United States |
| Carolina Arthritis | Wilmington | North Carolina | 28401 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas at Houston | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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