Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon

Raynaud's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266669
• Other study ID #: 05-002
• Secondary ID: MQX-503 In-Life
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2005
• Last updated: August 6, 2007
• Start date: December 2005
• Est. completion date: May 2006

Study information

• Verified date: August 2007
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud's Disease

Intervention

Drug:
• Topical organogel with nitroglycerin

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario
Canada	SMBD Jewish General Hospital	Montreal	Quebec
United States	The Center for Rheumatology	Albany	New York
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Center for Advanced Medicine	Chicago	Illinois
United States	University of Colorado at Denver and Health Sciences Center	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	SUNY Stony Brook	East Setauket	New York
United States	University of Connecticut	Farmington	Connecticut
United States	Arthritis Education & Treatment Center, PLLC	Grand Rapids	Michigan
United States	University of Texas Medical School at Houston	Houston	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Medicine and Dentistry of New Jersey	New Brunswick	New Jersey
United States	Virginia Mason Benaroya Research Institute	Seattle	Washington
United States	Stanford Medical School	Stanford	California
United States	Medical University of Ohio	Toledo	Ohio
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
MediQuest Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in Raynaud's Assessment Score comparing active to placebo
Primary	Reduction of number of Raynaud's events
Primary	Decrease in duration of Raynaud's events
Primary	Decrease in symptoms associated with Raynaud's
Primary	Assess safety: frequency and severity of adverse events associated with the study drug
Secondary	Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
Secondary	Reduction in emergence of digital ulcers for patients with scleroderma