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

Raynaud Disease Clinical Trial

Official title:

Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s Phenomenon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253331
• Other study ID #: MQT 03-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 13, 2005
• Last updated: May 29, 2007
• Start date: November 2004
• Est. completion date: September 2005

Study information

• Verified date: May 2007
• Source: MediQuest Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Autoimmune Diseases
• Neoplasm Metastasis
• Raynaud Disease
• Raynaud Disease Secondary to Scleroderma
• Raynaud Secondary to Other Autoimmune Disease

Intervention

Drug:
• topical organogel with nitroglycerin

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	University of Washington Medical College	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MediQuest Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differntial time for blood flow to return to baseline following cold exposure.
Secondary	Differential time for skin temperature to return to baseline following cold exposure.
Secondary	Quantitative reduction or prevention in symptoms following cold exposure.