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

Information source: MediQuest Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Raynaud's Disease

Intervention: Topical organogel with nitroglycerin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: MediQuest Therapeutics


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

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:

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


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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


- 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


Locations and Contacts

Stanford Medical School, Stanford, California 94305, United States

University of Colorado at Denver and Health Sciences Center, Denver, Colorado 80204, United States

University of Connecticut, Farmington, Connecticut 06030, United States

Georgetown University Medical Center, Washington, District of Columbia 20007, United States

University of Chicago Center for Advanced Medicine, Chicago, Illinois 60637, United States

Johns Hopkins Bayview Medical Center, Baltimore, Maryland 21224, United States

Boston University School of Medicine, Boston, Massachusetts 02118, United States

Arthritis Education & Treatment Center, PLLC, Grand Rapids, Michigan 49546, United States

University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey 08903, United States

The Center for Rheumatology, Albany, New York 12206, United States

SUNY Stony Brook, East Setauket, New York 11733, United States

Duke University, Durham, North Carolina 27710, United States

Medical University of Ohio, Toledo, Ohio 43614, United States

St. Joseph's Health Care, London, Ontario N6A 4V2, Canada

SMBD Jewish General Hospital, Montreal, Quebec H3T 1E2, Canada

Medical University of South Carolina, Charleston, South Carolina 29425, United States

University of Texas Medical School at Houston, Houston, Texas 77030, United States

Virginia Mason Benaroya Research Institute, Seattle, Washington 98101, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: December 2005
Last updated: August 6, 2007

Page last updated: August 23, 2015

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