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

NCT00253331 | Completed Phase 2

• 1 other identifier: MQT 03-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Raynaud's; sclerderma; systemic sclerosis; autoimmune disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• Differential time for skin temperature to return to baseline following cold exposure.

• Quantitative reduction or prevention in symptoms following cold exposure.

Interventions

topical organogel with nitroglycerin DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MediQuest Therapeutics: lead

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

University of Washington Medical College

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Raynaud Disease; Scleroderma, Systemic; Autoimmune Diseases

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Laura K Hummers, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Carin Dugowson, MD, MPH

  University of Washington Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2005
• First Posted: November 15, 2005
• Study Start: November 1, 2004
• Study Completion: September 1, 2005
• Last Updated: May 30, 2007

Record last verified: 2007-05

Locations

US (2)