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| Sponsor: | MediQuest Therapeutics |
|---|---|
| Information provided by: | MediQuest Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00934427 |
Purpose
The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.
| Condition | Intervention | Phase |
|---|---|---|
|
Raynaud Disease |
Drug: 0.9% nitroglycerin in TAM cream Drug: vehicle cream |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Vascana: Active Comparator |
Drug: 0.9% nitroglycerin in TAM cream
0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures
|
| Vehicle: Placebo Comparator |
Drug: vehicle cream
0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures
|
Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University | Recruiting |
| Redwood City, California, United States, 94063 | |
| Contact: Deborah Strahs 650-618-1681 | |
| Principal Investigator: David Fiorentino, MD | |
| United States, Connecticut | |
| University of Connecticut | Recruiting |
| Farmington, Connecticut, United States, 06030 | |
| Contact: Kim Schwartz 860-679-2589 | |
| Principal Investigator: Naomi Rothfield, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Maria B Alora-Palli, MD 617-724-1503 | |
| Principal Investigator: Alexa B Kimball, MD, MPH | |
| United States, Michigan | |
| Michigan State University | Active, not recruiting |
| Grand Rapids, Michigan, United States, 49546 | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| Contact: Ann Impens, PhD 734-936-1439 | |
| Principal Investigator: James Seibold, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Patt Carlson, B.S., C.C.R.P. 612-626-3736 | |
| Principal Investigator: Jerry Molitor, M.D., Ph.D. | |
| United States, New Jersey | |
| University of Medicine and Dentistry in New Jersey | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Halina Malveaux 732-418-8483 | |
| Principal Investigator: Viven Hsu, MD | |
| United States, New York | |
| The Center for Rheumatology | Not yet recruiting |
| Albany, New York, United States, 12206 | |
| Principal Investigator: Lee Shapiro, MD | |
| United States, North Carolina | |
| Carolina Arthritis | Recruiting |
| Wilmington, North Carolina, United States, 28401 | |
| Contact: Jodi Daniel 910-762-1182 | |
| Principal Investigator: Mark D. Harris, MD | |
| United States, Ohio | |
| University of Toledo | Recruiting |
| Toledo, Ohio, United States, 43614 | |
| Contact: Sharon Loukx RN, BSN, CCRC 419-383-6915 | |
| Principal Investigator: Bashar Kahaleh, MD | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Tara Barker, MSN, RN, CCRP (216) 445-6139 | |
| Principal Investigator: Soumya Chatterjee, M.D., M.S., F.R.C.P. | |
| United States, Texas | |
| University of Texas - Houston | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Maureen Mayes, MD | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Marit Johnson, RN 414-955-7022 | |
| Principal Investigator: Mary Ellen Csuka, MD | |
| Study Director: | Jeff Gregory, MD | MediQuest Therapeutics |
More Information
| Responsible Party: | MediQuest Therapeutics ( Jeff Gregory, MD / Medical Director ) |
| Study ID Numbers: | 09-001 |
| Study First Received: | June 26, 2009 |
| Last Updated: | February 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00934427 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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