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

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

September 18, 2006
September 20, 2006
May 30, 2007
July 2006
Not Provided
Measure the time required for blood flow to return to baseline after cold exposure
Same as current
Complete list of historical versions of study NCT00378521 on ClinicalTrials.gov Archive Site
  • Measure the time required for skin temperature to return to baseline after cold exposure
  • Prevention or reduction of symptoms following cold exposure.
Same as current
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Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon
Phase II Dose Response 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 the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
  • Raynaud's Disease
  • Raynaud's Disease Secondary to Scleroderma
  • Raynaud's Disease Secondary to Autoimmune Disease
Drug: MQX-503
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00378521
06-001
Not Provided
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MediQuest Therapeutics
Not Provided
Principal Investigator: Leslie Klaff, MD Rainier Clinical Research
MediQuest Therapeutics
May 2007

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