A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon

Study Description

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Brief Summary:

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 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

Detailed 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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
2; Placebo - Topical AmphiMatrix	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.
Active Comparator: 1; Topical AmphiMatrix with Nitroglycerin	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.

Outcome Measures

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Primary Outcome Measures :

1. Reduction in Raynaud's Condition Score [ Time Frame: three months ]

Secondary Outcome Measures :

1. Frequency and severity of adverse events. [ Time Frame: three months ]

Eligibility Criteria

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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

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

MediQuest Therapeutics

Investigators

Study Director:	Jan Ohrstrom, PhD	MediQuest Therapeutics

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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