Back to resultsLab Study of MQX-503 in Treatment of Raynaud's
Primary Purpose
Raynaud Disease, Raynaud Disease Secondary to Scleroderma, Raynaud Secondary to Other Autoimmune Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
topical organogel with nitroglycerin
Sponsored by
About this trial
This is an interventional prevention trial for Raynaud Disease focused on measuring Raynaud's, sclerderma, systemic sclerosis, autoimmune disease
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of Raynaud's phenomenon outpoatients agree to apply gel as per protocol willing to discontinue current vasodilator therapy agree to stop other investigational medication for Raynaud's negative pregnancy test is fertile females able to give written informed consent and comply with study requirements Exclusion Criteria: current use of ay nitrate medication or medications that interact with nitroglycerin patients with a known allergy to nitroglycerin or topical gel ingredients patients with a history of migraine headaches patients with unstable medical problems patients with cognitive or language difficulties patients with screening lab values more than 20% outside of normal patients with open lesions at site of application women of child-bearing potential who are unwilling to comply with contraceptive requirements.
Sites / Locations
- Johns Hopkins Bayview Medical Center
- University of Washington Medical College
Outcomes
Primary Outcome Measures
Differntial time for blood flow to return to baseline following cold exposure.
Secondary Outcome Measures
Differential time for skin temperature to return to baseline following cold exposure.
Quantitative reduction or prevention in symptoms following cold exposure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00253331
Brief Title
Lab Study of MQX-503 in Treatment of Raynaud's
Official Title
Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
MediQuest Therapeutics
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.
Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours.
Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud Disease, Raynaud Disease Secondary to Scleroderma, Raynaud Secondary to Other Autoimmune Disease
Keywords
Raynaud's, sclerderma, systemic sclerosis, autoimmune disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
topical organogel with nitroglycerin
Primary Outcome Measure Information:
Title
Differntial time for blood flow to return to baseline following cold exposure.
Secondary Outcome Measure Information:
Title
Differential time for skin temperature to return to baseline following cold exposure.
Title
Quantitative reduction or prevention in symptoms following cold exposure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of Raynaud's phenomenon
outpoatients
agree to apply gel as per protocol
willing to discontinue current vasodilator therapy
agree to stop other investigational medication for Raynaud's
negative pregnancy test is fertile females
able to give written informed consent and comply with study requirements
Exclusion Criteria:
current use of ay nitrate medication or medications that interact with nitroglycerin
patients with a known allergy to nitroglycerin or topical gel ingredients
patients with a history of migraine headaches
patients with unstable medical problems
patients with cognitive or language difficulties
patients with screening lab values more than 20% outside of normal
patients with open lesions at site of application
women of child-bearing potential who are unwilling to comply with contraceptive requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura K Hummers, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carin Dugowson, MD, MPH
Organizational Affiliation
University of Washington Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
University of Washington Medical College
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lab Study of MQX-503 in Treatment of Raynaud's
We'll reach out to this number within 24 hrs