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

Tracking Information
First Submitted Date ICMJE	November 13, 2005
First Posted Date ICMJE	November 15, 2005
Last Update Posted Date	May 30, 2007
Study Start Date ICMJE	November 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: November 13, 2005)	Differntial time for blood flow to return to baseline following cold exposure.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00253331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 13, 2005)	Differential time for skin temperature to return to baseline following cold exposure.; Quantitative reduction or prevention in symptoms following cold exposure.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Lab Study of MQX-503 in Treatment of Raynaud's
Official Title ICMJE	Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s Phenomenon
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double; Primary Purpose: Prevention
Condition ICMJE	Raynaud Disease; Raynaud Disease Secondary to Scleroderma; Raynaud Secondary to Other Autoimmune Disease
Intervention ICMJE	Drug: topical organogel with nitroglycerin
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: November 13, 2005)	36
Original Enrollment ICMJE	Same as current
Study Completion Date	September 2005
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00253331
Other Study ID Numbers ICMJE	MQT 03-001
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	MediQuest Therapeutics
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Laura K Hummers, MD Johns Hopkins University Principal Investigator: Carin Dugowson, MD, MPH University of Washington Medical College
PRS Account	MediQuest Therapeutics
Verification Date	May 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP