NCT00577304

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: MediQuest Therapeutics · Industry
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Raynaud's Disease
• Raynaud's Disease Secondary to Scleroderma
• Raynaud's Disease Secondary to Other Autoimmune Disease

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-12-20
• Last updated: 2010-02-05

Locations

17 sites across 1 country: United States