Clinical trial NCT00934427: Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Raynaud Disease
Keywords: Raynaud's
scleroderma
nitroglycerin
MQX-503
treatment
Lead sponsor: MediQuest Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)
timeFrame: 2 weeks
Secondary outcomes:
measure: Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)
timeFrame: 2 weeks
measure: Changes from baseline in duration of Raynaud's attacks
timeFrame: 2 weeks
measure: Changes from baseline in number of Raynaud's attacks
timeFrame: 2 weeks
measure: Changes from baseline in the Raynaud's Condition Score
timeFrame: 2 weeks
measure: Changes in the maximum reduction in skin temperature
timeFrame: 2 weeks
measure: Changes from baseline in overall disease severity measures
timeFrame: 2 weeks
measure: Changes in the time to return to baseline skin temperature
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Michigan State University
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New Brunswick
country: United States
facility: University of Medicine and Dentistry in New Jersey
state: New Jersey
city: Wilmington
country: United States
facility: Carolina Arthritis
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: MediQuest Therapeutics
name: Jeff Gregory, MD
role: STUDY_DIRECTOR
References: