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

NCT00577304 | Unknown Phase 3

• 1 other identifier: 07-005
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 17

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.

Conditions

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

Keywords

Raynaud's; Nitroglycerin; Scleroderma

Outcome Measures

Primary Outcomes (1)

• Reduction in Raynaud's Condition Score

  three months

Secondary Outcomes (1)

• Frequency and severity of adverse events.

  three months

Study Arms (2)

2

OTHER

Placebo - Topical AmphiMatrix

Drug: Topical AmphiMatrix

1

ACTIVE COMPARATOR

Topical AmphiMatrix with Nitroglycerin

Drug: Nitroglycerin

Interventions

Nitroglycerin 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.

1

Topical AmphiMatrix 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.

2

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MediQuest Therapeutics: lead

Study Sites (17)

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80045, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Boston University

Boston, Massachusetts, 02118, United States

Location

Arthritis Education and Treatment Center, PLLC

Grand Rapids, Michigan, 49546, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, 08093, United States

Location

The Center for Rheumatology

Albany, New York, 12206, United States

Location

SUNY Stony Brook

Stony Brook, New York, 11794, United States

Location

Carolina Arthritis

Wilmington, North Carolina, 28401, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas at Houston

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• Sponsor web site

MeSH Terms

Conditions

Raynaud Disease; Scleroderma, Diffuse

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Jan Ohrstrom, PhD

  MediQuest Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: December 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 5, 2010

Record last verified: 2008-04

Locations

US (17)