Lab Study of MQX-503 in Treatment of Raynaud's
Information source: MediQuest Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Raynaud Disease; Raynaud Disease Secondary to Scleroderma; Raynaud Secondary to Other Autoimmune Disease
Intervention: topical organogel with nitroglycerin (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: MediQuest Therapeutics Official(s) and/or principal investigator(s):
Laura K Hummers, MD, Principal Investigator, Affiliation: Johns Hopkins University
Carin Dugowson, MD, MPH, Principal Investigator, Affiliation: University of Washington Medical College
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.
Clinical Details
Official title: Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s Phenomenon
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Differntial time for blood flow to return to baseline following cold exposure.
Secondary outcome: Differential time for skin temperature to return to baseline following cold exposure.Quantitative reduction or prevention in symptoms following cold exposure.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- clinical diagnosis of Raynaud's phenomenon
- outpoatients
- agree to apply gel as per protocol
- willing to discontinue current vasodilator therapy
- agree to stop other investigational medication for Raynaud's
- negative pregnancy test is fertile females
- able to give written informed consent and comply with study requirements
Exclusion Criteria:
- current use of ay nitrate medication or medications that interact with nitroglycerin
- patients with a known allergy to nitroglycerin or topical gel ingredients
- patients with a history of migraine headaches
- patients with unstable medical problems
- patients with cognitive or language difficulties
- patients with screening lab values more than 20% outside of normal
- patients with open lesions at site of application
- women of child-bearing potential who are unwilling to comply with contraceptive
requirements.
Locations and Contacts
Johns Hopkins Bayview Medical Center, Baltimore, Maryland 21224, United States
University of Washington Medical College, Seattle, Washington 98195, United States
Additional Information
Starting date: November 2004
Ending date: September 2005
Last updated: May 29, 2007
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