Clinical trial NCT00266669: Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
Official title: Phase III "in-Life" Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Raynaud's Disease
Keywords: Raynaud's Phenomenon
Raynaud's Disease
Scleroderma
Raynaud's Disease Secondary to Scleroderma
Raynaud's Disease Secondary to Other Autoimmune Disease
Lead sponsor: MediQuest Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Raynaud's phenomenon
* 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:

* Current use of nitrate medications or medications known to interact with nitroglycerin
* 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

Primary outcomes:
measure: Improvements in Raynaud's Assessment Score comparing active to placebo
measure: Reduction of number of Raynaud's events
measure: Decrease in duration of Raynaud's events
measure: Decrease in symptoms associated with Raynaud's
measure: Assess safety: frequency and severity of adverse events associated with the study drug
Secondary outcomes:
measure: Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
measure: Reduction in emergence of digital ulcers for patients with scleroderma
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Medical School
state: California
city: Denver
country: United States
facility: University of Colorado at Denver and Health Sciences Center
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago Center for Advanced Medicine
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Grand Rapids
country: United States
facility: Arthritis Education & Treatment Center, PLLC
state: Michigan
city: New Brunswick
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Albany
country: United States
facility: The Center for Rheumatology
state: New York
city: East Setauket
country: United States
facility: SUNY Stony Brook
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Toledo
country: United States
facility: Medical University of Ohio
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: University of Texas Medical School at Houston
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Benaroya Research Institute
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
city: Montreal
country: Canada
facility: SMBD Jewish General Hospital
state: Quebec
Study officials:
References: