Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
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
1 other identifier
interventional
100
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2009
Shorter than P25 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 20, 2010
July 1, 2010
1 year
June 26, 2009
July 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)
2 weeks
Secondary Outcomes (7)
Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)
2 weeks
Changes from baseline in duration of Raynaud's attacks
2 weeks
Changes from baseline in number of Raynaud's attacks
2 weeks
Changes from baseline in the Raynaud's Condition Score
2 weeks
Changes in the maximum reduction in skin temperature
2 weeks
- +2 more secondary outcomes
Study Arms (2)
Vascana
ACTIVE COMPARATORVehicle
PLACEBO COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Stanford University
Redwood City, California, 94063, United States
University of Connecticut
Farmington, Connecticut, 06030, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48106, United States
Michigan State University
Grand Rapids, Michigan, 49546, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Medicine and Dentistry in New Jersey
New Brunswick, New Jersey, 08903, United States
Carolina Arthritis
Wilmington, North Carolina, 28401, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Toledo
Toledo, Ohio, 43614, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeff Gregory, MD
MediQuest Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 26, 2009
First Posted
July 8, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
July 20, 2010
Record last verified: 2010-07