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
Summary
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 placeboReduction 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 QuestionsReduction in emergence of digital ulcers for patients with scleroderma
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
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
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