Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by MediQuest Therapeutics.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
MediQuest Therapeutics
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00934427
First received: June 26, 2009
Last updated: July 19, 2010
Last verified: July 2010
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Raynaud's Disease
Drug Information available for:
Nitroglycerin
U.S. FDA Resources
Further study details as provided by MediQuest Therapeutics:
Primary Outcome Measures:
- Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in duration of Raynaud's attacks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in number of Raynaud's attacks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in the Raynaud's Condition Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Changes in the maximum reduction in skin temperature [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in overall disease severity measures [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Changes in the time to return to baseline skin temperature [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Vascana |
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
Other Name: Vascana
|
| Placebo Comparator: Vehicle |
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
|
Detailed Description:
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 |
Criteria
Inclusion Criteria:
- clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers
- a history of at least two Raynaud's events during a typical winter day
- must be willing to apply creams to fingers
- must be willing to undergo cold temperature exposure
- must be willing and able to stop certain medications
- must be willing to use effective contraception, if applicable
Exclusion Criteria:
- had a Raynaud's attack that required hospital or clinic intervention
- has allergies to nitroglycerin or topical medication ingredients
- has a history of migraine or chronic pain
- has an unstable medical problem that could interfere with the study
- had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months
- used any investigational drug in the past 4 weeks
- has significantly abnormal laboratory tests
- had certain major surgeries in the past 6 months
- has skin lesions on certain parts of the fingers
- women who are pregnant or nursing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934427
Locations
| United States, California | |
| Stanford University | |
| Redwood City, California, United States, 94063 | |
| United States, Connecticut | |
| University of Connecticut | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48106 | |
| Michigan State University | |
| 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 in New Jersey | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, North Carolina | |
| Carolina Arthritis | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| University of Toledo | |
| Toledo, Ohio, United States, 43614 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
MediQuest Therapeutics
Investigators
| Study Director: | Jeff Gregory, MD | MediQuest Therapeutics |
More Information
No publications provided
| Responsible Party: | Jeff Gregory, MD / Medical Director, MediQuest Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00934427 History of Changes |
| Other Study ID Numbers: | 09-001 |
| Study First Received: | June 26, 2009 |
| Last Updated: | July 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by MediQuest Therapeutics:
|
Raynaud's scleroderma nitroglycerin MQX-503 treatment |
Additional relevant MeSH terms:
|
Raynaud Disease Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Nitroglycerin |
Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013