Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
Information source: MediQuest Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Raynaud Disease
Intervention: 0.9% nitroglycerin in TAM cream (Drug); vehicle cream (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: MediQuest Therapeutics Official(s) and/or principal investigator(s):
Jeff Gregory, MD, Study Director, Affiliation: MediQuest Therapeutics
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)
Secondary outcome: Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)Changes from baseline in duration of Raynaud's attacks Changes from baseline in number of Raynaud's attacks Changes from baseline in the Raynaud's Condition Score Changes in the maximum reduction in skin temperature Changes from baseline in overall disease severity measures Changes in the time to return to baseline skin temperature
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
Starting date: June 2009
Last updated: July 19, 2010
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