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

Phase 3

Completed

• Conditions: Raynaud's Disease

• Registration Number: NCT00266669
• Lead Sponsor: MediQuest Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-15
• Study First Submitted QC: 2005-12-15
• Study First Posted: 2005-12-19
• Study Completion: 2006-05
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-06
• Last Update Posted: 2007-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvements in Raynaud's Assessment Score comparing active to placebo
Reduction of number of Raynaud's events
Decrease in duration of Raynaud's events
Decrease in symptoms associated with Raynaud's
Assess safety: frequency and severity of adverse events associated with the study drug

Secondary Outcome Measures

Name	Time	Method
Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
Reduction in emergence of digital ulcers for patients with scleroderma

Trial Locations

Locations (19)

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, 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

Scroll for more (9 remaining)