Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms - Full Text View

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

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 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

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	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

Sponsors and Collaborators

MediQuest Therapeutics

Investigators

Study Director:

Jeff Gregory, MD

MediQuest Therapeutics

More Information

No publications provided

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

Keywords provided by MediQuest Therapeutics:

Raynaud's
scleroderma
nitroglycerin
MQX-503
treatment

Additional relevant MeSH terms:

Nitroglycerin
Vasodilator Agents
Peripheral Vascular Diseases
Raynaud Disease
Therapeutic Uses

Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010