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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00253331
First Posted: November 15, 2005
Last Update Posted: May 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MediQuest Therapeutics
  Purpose

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.


Condition Intervention Phase
Raynaud Disease Raynaud Disease Secondary to Scleroderma Raynaud Secondary to Other Autoimmune Disease Drug: topical organogel with nitroglycerin Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s Phenomenon

Resource links provided by NLM:


Further study details as provided by MediQuest Therapeutics:

Primary Outcome Measures:
  • Differntial time for blood flow to return to baseline following cold exposure.

Secondary Outcome Measures:
  • Differential time for skin temperature to return to baseline following cold exposure.
  • Quantitative reduction or prevention in symptoms following cold exposure.

Estimated Enrollment: 36
Study Start Date: November 2004
Estimated Study Completion Date: September 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253331


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Washington
University of Washington Medical College
Seattle, Washington, United States, 98195
Sponsors and Collaborators
MediQuest Therapeutics
Investigators
Principal Investigator: Laura K Hummers, MD Johns Hopkins University
Principal Investigator: Carin Dugowson, MD, MPH University of Washington Medical College
  More Information

ClinicalTrials.gov Identifier: NCT00253331     History of Changes
Other Study ID Numbers: MQT 03-001
First Submitted: November 13, 2005
First Posted: November 15, 2005
Last Update Posted: May 30, 2007
Last Verified: May 2007

Keywords provided by MediQuest Therapeutics:
Raynaud's
sclerderma
systemic sclerosis
autoimmune disease

Additional relevant MeSH terms:
Neoplasm Metastasis
Autoimmune Diseases
Raynaud Disease
Neoplastic Processes
Neoplasms
Pathologic Processes
Immune System Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Nitroglycerin
Vasodilator Agents


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