Lab Study of MQX-503 in Treatment of Raynaud's - Full Text View

Sponsored by:	MediQuest Therapeutics
Information provided by:	MediQuest Therapeutics
ClinicalTrials.gov Identifier:	NCT00253331

Purpose

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.

Condition	Intervention	Phase
Raynaud Disease Raynaud Disease Secondary to Scleroderma Raynaud Secondary to Other Autoimmune Disease	Drug: topical organogel with nitroglycerin	Phase II Phase III

MedlinePlus related topics: Autoimmune Diseases Raynaud's Disease

Drug Information available for: Nitroglycerin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s Phenomenon

Further study details as provided by MediQuest Therapeutics:

Primary Outcome Measures:

Differntial time for blood flow to return to baseline following cold exposure.

Secondary Outcome Measures:

Differential time for skin temperature to return to baseline following cold exposure.
Quantitative reduction or prevention in symptoms following cold exposure.

Estimated Enrollment:	36
Study Start Date:	November 2004
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253331

Locations

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

Sponsors and Collaborators

MediQuest Therapeutics

Investigators

Principal Investigator:	Laura K Hummers, MD	Johns Hopkins University
Principal Investigator:	Carin Dugowson, MD, MPH	University of Washington Medical College

More Information

Study ID Numbers:	MQT 03-001
Study First Received:	November 13, 2005
Last Updated:	May 29, 2007
ClinicalTrials.gov Identifier:	NCT00253331
Health Authority:	United States: Food and Drug Administration

Keywords provided by MediQuest Therapeutics:

Raynaud's
sclerderma
systemic sclerosis
autoimmune disease

Study placed in the following topic categories:

Nitroglycerin
Peripheral Vascular Diseases
Autoimmune Diseases
Raynaud Disease

Vascular Diseases
Neoplasm Metastasis
Sclerosis
Scleroderma, Systemic

Additional relevant MeSH terms:

Vasodilator Agents
Neoplasms
Neoplastic Processes
Pathologic Processes
Immune System Diseases

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009