A Study of a Topical Form of Nitroglycerin and Placebo in the 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; Raynaud's Disease Secondary to Scleroderma; Raynaud's Disease Secondary to Other Autoimmune Disease
Intervention: Nitroglycerin (Drug); Topical AmphiMatrix (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: MediQuest Therapeutics Official(s) and/or principal investigator(s):
Jan Ohrstrom, PhD, Study Director, Affiliation: MediQuest Therapeutics
Summary
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.
Clinical Details
Official title: A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Reduction in Raynaud's Condition Score
Secondary outcome: Frequency and severity of adverse events.
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.
Eligibility
Minimum age: 15 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Stanford University, Stanford, California 94305, United States
University of Colorado Health Sciences Center, Denver, Colorado 80045, United States
University of Connecticut, Farmington, Connecticut 06030, United States
Georgetown University, Washington, District of Columbia 20007, United States
University of Chicago, Chicago, Illinois 60637, United States
Johns Hopkins University, Baltimore, Maryland 21224, United States
Boston University, Boston, Massachusetts 02118, United States
Arthritis Education and Treatment Center, PLLC, Grand Rapids, Michigan 49546, United States
University of Minnesota, Minneapolis, Minnesota 55455, United States
University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey 08093, United States
The Center for Rheumatology, Albany, New York 12206, United States
SUNY Stony Brook, Stony Brook, New York 11794, United States
Carolina Arthritis, Wilmington, North Carolina 28401, United States
University of Toledo, Toledo, Ohio 43614, United States
Medical University of South Carolina, Charleston, South Carolina 29425, United States
University of Texas at Houston, Houston, Texas 77030, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Additional Information
Sponsor web site
Starting date: December 2007
Last updated: February 3, 2010
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