Lab Study of MQX-503 in Treatment of Raynaud's
The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.
Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours.
Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.
|Raynaud Disease Raynaud Disease Secondary to Scleroderma Raynaud Secondary to Other Autoimmune Disease||Drug: topical organogel with nitroglycerin||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s Phenomenon|
- Differntial time for blood flow to return to baseline following cold exposure.
- Differential time for skin temperature to return to baseline following cold exposure.
- Quantitative reduction or prevention in symptoms following cold exposure.
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||September 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253331
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|United States, Washington|
|University of Washington Medical College|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Laura K Hummers, MD||Johns Hopkins University|
|Principal Investigator:||Carin Dugowson, MD, MPH||University of Washington Medical College|