A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by MediQuest Therapeutics.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00577304
First Posted: December 20, 2007
Last Update Posted: February 5, 2010
Information provided by:
MediQuest Therapeutics
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Raynaud's Disease Raynaud's Disease Secondary to Scleroderma Raynaud's Disease Secondary to Other Autoimmune Disease | Drug: Nitroglycerin Drug: Topical AmphiMatrix | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon |
Resource links provided by NLM:
Genetics Home Reference related topics:
systemic scleroderma
Drug Information available for:
Nitroglycerin
U.S. FDA Resources
Further study details as provided by MediQuest Therapeutics:
Primary Outcome Measures:
- Reduction in Raynaud's Condition Score [ Time Frame: three months ]
Secondary Outcome Measures:
- Frequency and severity of adverse events. [ Time Frame: three months ]
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | March 2008 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
2
Placebo - Topical AmphiMatrix
|
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.
|
|
Active Comparator: 1
Topical AmphiMatrix with Nitroglycerin
|
Drug: 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.
|
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
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| Ages Eligible for Study: | 15 Years to 70 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577304
Locations
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80045 | |
| United States, Connecticut | |
| University of Connecticut | |
| Farmington, Connecticut, United States, 06030 | |
| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Boston University | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Arthritis Education and Treatment Center, PLLC | |
| Grand Rapids, Michigan, United States, 49546 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New Jersey | |
| University of Medicine and Dentistry of New Jersey | |
| New Brunswick, New Jersey, United States, 08093 | |
| United States, New York | |
| The Center for Rheumatology | |
| Albany, New York, United States, 12206 | |
| SUNY Stony Brook | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Carolina Arthritis | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, Ohio | |
| University of Toledo | |
| Toledo, Ohio, United States, 43614 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| University of Texas at Houston | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
MediQuest Therapeutics
Investigators
| Study Director: | Jan Ohrstrom, PhD | MediQuest Therapeutics |
More Information
Additional Information:
| Responsible Party: | Fred Dechow/President and CEO, MediQuest Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00577304 History of Changes |
| Other Study ID Numbers: |
07-005 |
| First Submitted: | December 18, 2007 |
| First Posted: | December 20, 2007 |
| Last Update Posted: | February 5, 2010 |
| Last Verified: | April 2008 |
Keywords provided by MediQuest Therapeutics:
|
Raynaud's Nitroglycerin Scleroderma |
Additional relevant MeSH terms:
|
Raynaud Disease Neoplasm Metastasis Scleroderma, Systemic Scleroderma, Diffuse Autoimmune Diseases Neoplastic Processes Neoplasms Pathologic Processes |
Connective Tissue Diseases Skin Diseases Immune System Diseases Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Nitroglycerin Vasodilator Agents |