Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon

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

The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma.

Study Overview

• Status: Completed
• Conditions: Raynaud's Disease
• Intervention / Treatment: Drug: Topical organogel with nitroglycerin

• Study Type: Interventional
• Enrollment: 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Health Care
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • SMBD Jewish General Hospital
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Medical School
  • Colorado
    • Denver, Colorado, United States, 80204
      • University of Colorado at Denver and Health Sciences Center
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Center for Advanced Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University School Of Medicine
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Arthritis Education & Treatment Center, PLLC
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • University of Medicine and Dentistry of New Jersey
  • New York
    • Albany, New York, United States, 12206
      • The Center for Rheumatology
    • East Setauket, New York, United States, 11733
      • SUNY Stony Brook
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Toledo, Ohio, United States, 43614
      • Medical University of Ohio
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Medical School at Houston
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Benaroya Research Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Raynaud's phenomenon
• 2 or more Raynaud's events on a typical winter day
• Agree to discontinue current treatments for Raynaud's
• Negative pregnancy test and agree to use effective contraception during study

Exclusion Criteria:

• Current use of nitrate medications or medications known to interact with nitroglycerin
• Patients who currently use medications, like calcium channel blockers, that might interfere with study medication
• Patients with a known allergy to nitroglycerin or common topical ingredients
• Patients with a history of migraine headaches
• Patients with a history of unstable medical problems
• Patients with cognitive or language difficulties that would impair completion of assessment instruments
• Patients with lab screening values more than 20% outside normal range
• Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening
• Pregnant or nursing women
• Women of child-bearing potential who are unwilling to comply with the contraceptive requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvements in Raynaud's Assessment Score comparing active to placebo
Reduction of number of Raynaud's events
Decrease in duration of Raynaud's events
Decrease in symptoms associated with Raynaud's
Assess safety: frequency and severity of adverse events associated with the study drug

Secondary Outcome Measures

Outcome Measure
Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
Reduction in emergence of digital ulcers for patients with scleroderma

Collaborators and Investigators

• Sponsor: MediQuest Therapeutics

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Study Completion: May 1, 2006

Study Registration Dates

• First Submitted: December 15, 2005
• First Submitted That Met QC Criteria: December 15, 2005
• First Posted (ESTIMATE): December 19, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2007
• Last Update Submitted That Met QC Criteria: August 6, 2007
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Keywords: Scleroderma; Raynaud's Disease; Raynaud's Phenomenon; Raynaud's Disease Secondary to Scleroderma; Raynaud's Disease Secondary to Other Autoimmune Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Peripheral Vascular Diseases; Raynaud Disease; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 05-002; MQX-503 In-Life