Clinical trial NCT00253331: Lab Study of MQX-503 in Treatment of Raynaud's
Official title: Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Raynaud Disease
Raynaud Disease Secondary to Scleroderma
Raynaud Secondary to Other Autoimmune Disease
Keywords: Raynaud's
sclerderma
systemic sclerosis
autoimmune disease
Lead sponsor: MediQuest Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Differntial time for blood flow to return to baseline following cold exposure.
Secondary outcomes:
measure: Differential time for skin temperature to return to baseline following cold exposure.
measure: Quantitative reduction or prevention in symptoms following cold exposure.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Seattle
country: United States
facility: University of Washington Medical College
state: Washington
Study officials:
affiliation: Johns Hopkins University
name: Laura K Hummers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington Medical College
name: Carin Dugowson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: