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

Raynaud's Disease Clinical Trial

Official title:

A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00577304
• Other study ID #: 07-005
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 18, 2007
• Last updated: February 3, 2010
• Start date: December 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: MediQuest Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Diseases
• Neoplasm Metastasis
• Raynaud Disease
• Raynaud's Disease
• Raynaud's Disease Secondary to Other Autoimmune Disease
• Raynaud's Disease Secondary to Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Center for Rheumatology	Albany	New York
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston University	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	University of Connecticut	Farmington	Connecticut
United States	Arthritis Education and Treatment Center, PLLC	Grand Rapids	Michigan
United States	University of Texas at Houston	Houston	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Medicine and Dentistry of New Jersey	New Brunswick	New Jersey
United States	Stanford University	Stanford	California
United States	SUNY Stony Brook	Stony Brook	New York
United States	University of Toledo	Toledo	Ohio
United States	Georgetown University	Washington	District of Columbia
United States	Carolina Arthritis	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MediQuest Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Raynaud's Condition Score		three months	No
Secondary	Frequency and severity of adverse events.		three months	Yes

External Links

•   Sponsor web site