Back to resultsDose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon
Primary Purpose
Raynaud's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitroglycerin
Sponsored by
About this trial
This is an interventional treatment trial for Raynaud's Disease focused on measuring Raynaud's phenomenon, Raynaud's Disease, Raynaud's disease secondary to scleroderma, Raynaud's phenomenon secondary to autoimmune disease
Eligibility Criteria
Inclusion Criteria:
- Patients with Raynaud's phenomenon
- Patients who are willing to discontinue any current therapies for Raynaud's phenomenon
Exclusion Criteria:
- The use of any medication containing nitroglycerin or known to interact with nitroglycerin
- Patients with a history of migraine or other severe headaches
- Open skin lesions or skin conditions in the area where medication is to be applied
- Pregnant or nursing women or those wishing to become pregnant.
Sites / Locations
- The Center for Rheumatology
Outcomes
Primary Outcome Measures
Changes in blood flow in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures.
Secondary Outcome Measures
Reduction in skin temperature recovery time and symptoms in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures.
Frequency and severity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00480753
Brief Title
Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon
Official Title
Phase II Dose Response 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
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MediQuest Therapeutics
4. Oversight
5. Study Description
Brief Summary
The purpose of this clinical study is to determine the response to two different dosage strengths of a topical nitroglycerin gel in patients with Raynaud's Phenomenon. Patient fingers will be monitored for changes in blood flow and skin temperature. Symptoms of pain, tingling and numbness will also be monitored.
Detailed Description
It is the intention of this protocol to study, in a controlled manner, the response of fingers of patients with Raynaud's phenomenon to two dosage strengths of a fast acting topical formulation of Nitroglycerin, MQX-503. Patients may have moderate to severe primary Raynaud's phenomenon or Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.
Quantitative changes in blood flow in the fingers of the non-dominant hand will be measured after the clinical induction of constriction of blood vessels by exposure to local cold temperatures. Secondarily, the quantitative reduction in skin temperature recovery time and symptoms of pain, tingling and numbness associated with Raynaud's phenomenon will be evaluated using a patient hand symptom analog assessment score. The frequency and severity of adverse events associated with MQX-503 will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Disease
Keywords
Raynaud's phenomenon, Raynaud's Disease, Raynaud's disease secondary to scleroderma, Raynaud's phenomenon secondary to autoimmune disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Primary Outcome Measure Information:
Title
Changes in blood flow in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures.
Time Frame
130 minutes
Secondary Outcome Measure Information:
Title
Reduction in skin temperature recovery time and symptoms in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures.
Time Frame
130 minutes
Title
Frequency and severity of adverse events
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Raynaud's phenomenon
Patients who are willing to discontinue any current therapies for Raynaud's phenomenon
Exclusion Criteria:
The use of any medication containing nitroglycerin or known to interact with nitroglycerin
Patients with a history of migraine or other severe headaches
Open skin lesions or skin conditions in the area where medication is to be applied
Pregnant or nursing women or those wishing to become pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Shapiro, MD
Organizational Affiliation
The Center for Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon
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