Phase III Study of a Topical Gel Formulation for Treatment and Prevention 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: NCT00419419
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : May 30, 2007
Information provided by:
MediQuest Therapeutics

Brief Summary:
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers.

Condition or disease Intervention/treatment Phase
Raynaud's Disease Scleroderma Autoimmune Diseases Drug: Topical AmphiMatrix with nitroglycerin (MQX-503) Phase 3

Detailed Description:
The purpose of this clinical study is to determine, in a controlled fashion, the ability of Topical AmphiMatrix formulation with Nitroglycerin (MQX-503) to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase III "In-Life" Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon
Study Start Date : December 2006

Primary Outcome Measures :
  1. Reduction in Raynaud's Condition Score

Secondary Outcome Measures :
  1. Frequency and Severity of adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Outpatients, 18 years to 70 years.
  • Patients with a clinical diagnosis of Raynaud’s phenomenon.
  • Patients who are willing to discontinue current vasodilator therapies.
  • Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud’s phenomenon and its symptoms while participating in this study.
  • Negative pregnancy test in fertile women.
  • Patients who are able to give written informed consent and comply with all study requirements.

Exclusion Criteria:

  • Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
  • Patients who concurrently use any medication or device which might interfere with the study medication.
  • Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
  • Patients with a history of headaches.
  • Patients who have a history of an unstable medical problem.
  • Patients with cognitive or language difficulties.
  • Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
  • Patients who participated in a study of any investigational drug within four weeks prior to Visit 1.
  • Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal.
  • Patients who have had major surgery within six months of Visit 1.
  • Patients with interfering skin conditions.
  • Pregnant or nursing women.

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): NCT00419419

United States, California
Standford Medical School
Stanford, California, United States, 94305
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, New York
The Center for Rheumatology
Albany, New York, United States, 12206
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Lund University Hospital
Lund, Sweden, 221 185
United Kingdom
Royal National Hospital for Rheumatic Diseases
Bath, United Kingdom, LX1 3EX
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
University of Leeds
Leeds, United Kingdom, LS7 4SA
Royal Free Hospital
London, United Kingdom, NW3 2QH
Hope Hospital
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
MediQuest Therapeutics Identifier: NCT00419419     History of Changes
Other Study ID Numbers: 06-005
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: May 2007

Keywords provided by MediQuest Therapeutics:

Additional relevant MeSH terms:
Autoimmune Diseases
Raynaud Disease
Immune System Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasodilator Agents