Clinical trial NCT00577304: A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Raynaud's Disease
Raynaud's Disease Secondary to Scleroderma
Raynaud's Disease Secondary to Other Autoimmune Disease
Keywords: Raynaud's
Nitroglycerin
Scleroderma
Lead sponsor: MediQuest Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-12-20
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Reduction in Raynaud's Condition Score
timeFrame: three months
Secondary outcomes:
measure: Frequency and severity of adverse events.
timeFrame: three months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Grand Rapids
country: United States
facility: Arthritis Education and Treatment Center, PLLC
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
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: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Wilmington
country: United States
facility: Carolina Arthritis
state: North Carolina
city: Toledo
country: United States
facility: University of Toledo
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 at Houston
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: MediQuest Therapeutics
name: Jan Ohrstrom, PhD
role: STUDY_DIRECTOR
References: