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Lab Study of MQX-503 in Treatment of Raynaud's

NCT00253331 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2007-05-30

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

topical organogel with nitroglycerin

Sponsors & Collaborators

  • MediQuest Therapeutics

    lead INDUSTRY

Principal Investigators

  • Laura K Hummers, MD · Johns Hopkins University

  • Carin Dugowson, MD, MPH · University of Washington Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Completion
2005-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00253331 on ClinicalTrials.gov