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

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.

Study Overview

• Status: Unknown
• Conditions: Raynaud Disease
• Intervention / Treatment: Drug: 0.9% nitroglycerin in TAM cream; Drug: vehicle cream

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Michigan State University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • University of Medicine and Dentistry in New Jersey
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Carolina Arthritis
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Toledo, Ohio, United States, 43614
      • University of Toledo
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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 Names: Vascana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Changes from baseline in overall disease severity measures	2 weeks
Changes in the time to return to baseline skin temperature	2 weeks

Collaborators and Investigators

• Sponsor: MediQuest Therapeutics
• Investigators: Study Director: Jeff Gregory, MD, MediQuest Therapeutics

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: June 26, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): July 20, 2010
• Last Update Submitted That Met QC Criteria: July 19, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: treatment; scleroderma; nitroglycerin; Raynaud's; MQX-503
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Peripheral Vascular Diseases; Raynaud Disease; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 09-001 (SIUH IRB)