NCT00934427

Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: MediQuest Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.

Detailed description

Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.

Conditions

• Raynaud Disease

Interventions

Type	Name	Description
DRUG	0.9% nitroglycerin in TAM cream	0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures
DRUG	vehicle cream	0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2009-07-08
• Last updated: 2010-07-20

Locations

11 sites across 1 country: United States