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

NCT ID: NCT00577304

Last Updated: 2010-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-03-31

Brief 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.

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.

Conditions

Raynaud's Disease; Raynaud's Disease Secondary to Scleroderma; Raynaud's Disease Secondary to Other Autoimmune Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

2

Placebo - Topical AmphiMatrix

Group Type: OTHER

Topical AmphiMatrix

Intervention Type: DRUG

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.

1

Topical AmphiMatrix with Nitroglycerin

Group Type: ACTIVE_COMPARATOR

Nitroglycerin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MediQuest Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

MediQuest Therapeutics, Inc.

Principal Investigators

Jan Ohrstrom, PhD

Role: STUDY_DIRECTOR

MediQuest Therapeutics

Locations

Stanford University

Stanford, California, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

University of Connecticut

Farmington, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston University

Boston, Massachusetts, United States

Arthritis Education and Treatment Center, PLLC

Grand Rapids, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, United States

The Center for Rheumatology

Albany, New York, United States

SUNY Stony Brook

Stony Brook, New York, United States

Carolina Arthritis

Wilmington, North Carolina, United States

University of Toledo

Toledo, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas at Houston

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Related Links

http://www.mqti.com

Sponsor web site

Other Identifiers

07-005

Identifier Type: -

Identifier Source: org_study_id