Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
NCT ID: NCT00266669
Last Updated: 2007-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2005-12-31
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Topical organogel with nitroglycerin
Eligibility Criteria
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Inclusion Criteria
* 2 or more Raynaud's events on a typical winter day
* Agree to discontinue current treatments for Raynaud's
* Negative pregnancy test and agree to use effective contraception during study
Exclusion Criteria
* Patients who currently use medications, like calcium channel blockers, that might interfere with study medication
* Patients with a known allergy to nitroglycerin or common topical ingredients
* Patients with a history of migraine headaches
* Patients with a history of unstable medical problems
* Patients with cognitive or language difficulties that would impair completion of assessment instruments
* Patients with lab screening values more than 20% outside normal range
* Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening
* Pregnant or nursing women
* Women of child-bearing potential who are unwilling to comply with the contraceptive requirements
18 Years
70 Years
ALL
No
Sponsors
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MediQuest Therapeutics
INDUSTRY
Locations
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Stanford Medical School
Stanford, California, United States
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States
University of Connecticut
Farmington, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Center for Advanced Medicine
Chicago, Illinois, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Arthritis Education & Treatment Center, PLLC
Grand Rapids, Michigan, United States
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States
The Center for Rheumatology
Albany, New York, United States
SUNY Stony Brook
East Setauket, New York, United States
Duke University
Durham, North Carolina, United States
Medical University of Ohio
Toledo, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Medical School at Houston
Houston, Texas, United States
Virginia Mason Benaroya Research Institute
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
St. Joseph's Health Care
London, Ontario, Canada
SMBD Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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MQX-503 In-Life
Identifier Type: -
Identifier Source: secondary_id
05-002
Identifier Type: -
Identifier Source: org_study_id