A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon

A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon

The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase blood flow to the fingers.

Study Overview

• Status: Unknown
• Conditions: Raynaud's Disease; Raynaud's Disease Secondary to Scleroderma; Raynaud's Disease Secondary to Other Autoimmune Disease
• Intervention / Treatment: Drug: Topical AmphiMatrix; Drug: Nitroglycerin

Detailed Description

The purpose of this clinical study is to determine, in a controlled fashion, the ability of a topical formulation of 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 (RP) and with moderate to severe Raynaud's Phenomenon secondary to autoimmune diseases, such as scleroderma.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Health Sciences Center
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Arthritis Education and Treatment Center, PLLC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • New Jersey
    • New Brunswick, New Jersey, United States, 08093
      • University of Medicine and Dentistry of New Jersey
  • New York
    • Albany, New York, United States, 12206
      • The Center for Rheumatology
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Carolina Arthritis
  • Ohio
    • Toledo, Ohio, United States, 43614
      • University of Toledo
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas at Houston
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Outpatients ages 15 - 70.
• Patients with a diagnosis of Raynaud's phenomenon.
• Patients who agree to apply study medication to their fingers.
• Patients who are willing to stop current topical vasodilator therapies.
• Patients who agree not to start or change dosage of current oral vasodilator therapies.
• Patients who agree not to use any nitrate therapy while participating in this study.
• Negative pregnancy test in fertile women and agreement to use effective contraception throughout the study.

Exclusion Criteria:

• Patients who currently use nitrate medication or medications known to interact with nitroglycerin.
• Patients who have an allergy to nitroglycerin or common topical gel ingredients.
• Patients with a history of severe headaches.
• Patients with an unstable medical problem.
• Patients with cognitive or language difficulties that would impair their ability to complete assessment of pain instruments.
• Patients who have had a recent heart attack or other uncontrolled heart condition.
• Patients who have participated in an investigational drug study within four weeks of visit one.
• Patients who have clinically significant abnormal lab values.
• Patients who have had recent major abdominal, thoracic or vascular surgery.
• Patients with interfering skin conditions.
• Pregnant or nursing women or women unwilling to comply with contraceptive requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 2; Placebo - Topical AmphiMatrix	Drug: Topical AmphiMatrix; Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
Active Comparator: 1; Topical AmphiMatrix with Nitroglycerin	Drug: Nitroglycerin; Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix with Nitroglycerin. Each dose contains 4.5mg of Nitroglycerin. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in Raynaud's Condition Score	three months

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency and severity of adverse events.	three months

Collaborators and Investigators

• Sponsor: MediQuest Therapeutics
• Investigators: Study Director: Jan Ohrstrom, PhD, MediQuest Therapeutics

Publications and helpful links

Helpful Links

• Sponsor web site

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Anticipated): March 1, 2008
• Study Completion (Anticipated): March 1, 2008

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 18, 2007
• First Posted (Estimate): December 20, 2007

Study Record Updates

• Last Update Posted (Estimate): February 5, 2010
• Last Update Submitted That Met QC Criteria: February 3, 2010
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: Scleroderma; Nitroglycerin; Raynaud's
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immune System Diseases; Neoplasms; Connective Tissue Diseases; Neoplastic Processes; Peripheral Vascular Diseases; Neoplasm Metastasis; Scleroderma, Systemic; Scleroderma, Diffuse; Autoimmune Diseases; Raynaud Disease; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 07-005