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

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ClinicalTrials.gov Identifier: NCT00253331
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : May 30, 2007
Sponsor:
Information provided by:
MediQuest Therapeutics

November 13, 2005
November 15, 2005
May 30, 2007
November 2004
Not Provided
Differntial time for blood flow to return to baseline following cold exposure.
Same as current
Complete list of historical versions of study NCT00253331 on ClinicalTrials.gov Archive Site
  • Differential time for skin temperature to return to baseline following cold exposure.
  • Quantitative reduction or prevention in symptoms following cold exposure.
Same as current
Not Provided
Not Provided
 
Lab Study of MQX-503 in Treatment of Raynaud's
Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s Phenomenon

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
  • Raynaud Disease
  • Raynaud Disease Secondary to Scleroderma
  • Raynaud Secondary to Other Autoimmune Disease
Drug: topical organogel with nitroglycerin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Same as current
September 2005
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00253331
MQT 03-001
Not Provided
Not Provided
Not Provided
Not Provided
MediQuest Therapeutics
Not Provided
Principal Investigator: Laura K Hummers, MD Johns Hopkins University
Principal Investigator: Carin Dugowson, MD, MPH University of Washington Medical College
MediQuest Therapeutics
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP