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Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon

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. Identifier: NCT00378521
Recruitment Status : Completed
First Posted : September 20, 2006
Last Update Posted : May 30, 2007
Information provided by:
MediQuest Therapeutics

Brief Summary:
The Purpose of this study is to determine the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease.

Condition or disease Intervention/treatment Phase
Raynaud's Disease Raynaud's Disease Secondary to Scleroderma Raynaud's Disease Secondary to Autoimmune Disease Drug: MQX-503 Phase 2

Detailed Description:
The Purpose of this clinical study is to determine, in a controlled fashion, the response to two dosage strengths of a topical gel formulation of Nitroglycerin, MQX-503, in the determination of changes in finger blood flow and skin temperature in the fingers of patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma. The dosage strength response in the treatment of the symptoms (pain, tingling, numbness) will also be monitored.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
Study Start Date : July 2006
Actual Study Completion Date : July 2006

Primary Outcome Measures :
  1. Measure the time required for blood flow to return to baseline after cold exposure

Secondary Outcome Measures :
  1. Measure the time required for skin temperature to return to baseline after cold exposure
  2. Prevention or reduction of symptoms following cold exposure.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Outpatients, 18 to 75 years
  • Clinical Diagnosis of Raynaud's, or observed event by study physician, or symptoms with reduced blood flow as meausred using laser doppler equipment
  • Agree to have test gels applied to finger
  • Discontinue current vasodialator therapeis for Raynaud's treatment
  • Four weeks from last clinical trial participation
  • Agree not to use any other investigational medications or therapies to treat Raynaud's and its symptoms while participating in this study including other dosages or forms of nitroglycerin, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, and verapamil
  • Negative pregnancy test for women prior to study start and agree to use effective contraception throughout
  • Must be able to give written informed consent and comply with all study requirements

Exclusion Criteria:

  • Concurrent use of any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction
  • Patients who have a known allergy to Nitroglycerin or common topical gel ingredients
  • Patients with a history of migraine, cluster or vascular headaches, or those who suffer from chronic pain
  • Patients with a history of an unstable medical problem or any current condition that would interfere in participation in the study
  • Patients unable to complete pain assessment instructions
  • Patients who in the last three months have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension
  • Patients who have participated in another investigational drug study within four weeks of the first study treatment
  • Patients with out of range laboratory screening values
  • Patients who have had major abdominal, thoracic or vascular surgery within six months of the first study treatment
  • Patients with open lesions or skin conditions where gel is to be applied
  • Pregnant or nursing women
  • Women who will not agree to comply with contraceptive requirements
  • Patients with a history of poor compliance, poor cooperation or unreliability

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 identifier (NCT number): NCT00378521

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United States, Washington
Rainier Clinical Research
Renton, Washington, United States, 98055
Sponsors and Collaborators
MediQuest Therapeutics
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Principal Investigator: Leslie Klaff, MD Rainier Clinical Research

Layout table for additonal information Identifier: NCT00378521     History of Changes
Other Study ID Numbers: 06-001
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: May 2007
Keywords provided by MediQuest Therapeutics:
topical gel
cold hands
painful hands
Additional relevant MeSH terms:
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Neoplasm Metastasis
Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Autoimmune Diseases
Neoplastic Processes
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Immune System Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasodilator Agents