A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
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ClinicalTrials.gov Identifier: NCT00577304 |
Recruitment Status
: Unknown
Verified April 2008 by MediQuest Therapeutics.
Recruitment status was: Active, not recruiting
First Posted
: December 20, 2007
Last Update Posted
: February 5, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Raynaud's Disease Raynaud's Disease Secondary to Scleroderma Raynaud's Disease Secondary to Other Autoimmune Disease | Drug: Nitroglycerin Drug: Topical AmphiMatrix | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon |
Study Start Date : | December 2007 |
Estimated Primary Completion Date : | March 2008 |
Estimated Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
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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Active Comparator: 1
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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- Reduction in Raynaud's Condition Score [ Time Frame: three months ]
- Frequency and severity of adverse events. [ Time Frame: three months ]

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Ages Eligible for Study: | 15 Years to 70 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577304
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 | |
The Center for Rheumatology | |
Albany, New York, United States, 12206 | |
SUNY Stony Brook | |
Stony Brook, New York, United States, 11794 | |
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: | Fred Dechow/President and CEO, MediQuest Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00577304 History of Changes |
Other Study ID Numbers: |
07-005 |
First Posted: | December 20, 2007 Key Record Dates |
Last Update Posted: | February 5, 2010 |
Last Verified: | April 2008 |
Keywords provided by MediQuest Therapeutics:
Raynaud's Nitroglycerin Scleroderma |
Additional relevant MeSH terms:
Raynaud Disease Neoplasm Metastasis Scleroderma, Systemic Scleroderma, Diffuse Autoimmune Diseases Neoplastic Processes Neoplasms Pathologic Processes |
Connective Tissue Diseases Skin Diseases Immune System Diseases Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Nitroglycerin Vasodilator Agents |