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

This study has been completed.
Sponsor:
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00378521
First received: September 18, 2006
Last updated: May 29, 2007
Last verified: May 2007
History of Changes
  Purpose

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 Intervention Phase
Raynaud's Disease
Raynaud's Disease Secondary to Scleroderma
Raynaud's Disease Secondary to Autoimmune Disease
 Drug: MQX-503
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MediQuest Therapeutics:

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

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

Estimated Enrollment: 15
Study Start Date: July 2006
Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378521

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

No publications provided

ClinicalTrials.gov Identifier: NCT00378521     History of Changes
Other Study ID Numbers: 06-001
Study First Received: September 18, 2006
Last Updated: May 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by MediQuest Therapeutics:
Raynaud's
Nitroglycerin
topical gel
 cold hands
painful hands
scleroderma

Additional relevant MeSH terms:
Autoimmune Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Raynaud Disease
Immune System Diseases
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
 Vascular Diseases
Cardiovascular Diseases
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013