Back to resultsPhase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
Primary Purpose
Raynaud's Disease, Scleroderma, Autoimmune Diseases
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Topical AmphiMatrix with nitroglycerin (MQX-503)
Sponsored by
About this trial
This is an interventional treatment trial for Raynaud's Disease focused on measuring Raynaud's
Eligibility Criteria
Inclusion Criteria:
- Outpatients, 18 years to 70 years.
- Patients with a clinical diagnosis of Raynaud's phenomenon.
- Patients who are willing to discontinue current vasodilator therapies.
- Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud's phenomenon and its symptoms while participating in this study.
- Negative pregnancy test in fertile women.
- Patients who are able to give written informed consent and comply with all study requirements.
Exclusion Criteria:
- Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
- Patients who concurrently use any medication or device which might interfere with the study medication.
- Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
- Patients with a history of headaches.
- Patients who have a history of an unstable medical problem.
- Patients with cognitive or language difficulties.
- Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
- Patients who participated in a study of any investigational drug within four weeks prior to Visit 1.
- Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal.
- Patients who have had major surgery within six months of Visit 1.
- Patients with interfering skin conditions.
- Pregnant or nursing women.
Sites / Locations
- Standford Medical School
- University of Connecticut
- Georgetown University Medical Center
- Johns Hopkins Bayview Medical Center
- The Center for Rheumatology
- Duke University
- Lund University Hospital
- Royal National Hospital for Rheumatic Diseases
- Ninewells Hospital and Medical School
- University of Leeds
- Royal Free Hospital
- Hope Hospital
Outcomes
Primary Outcome Measures
Reduction in Raynaud's Condition Score
Secondary Outcome Measures
Frequency and Severity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419419
Brief Title
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
Official Title
Phase III "In-Life" Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
MediQuest Therapeutics
4. Oversight
5. Study Description
Brief Summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers.
Detailed Description
The purpose of this clinical study is to determine, in a controlled fashion, the ability of Topical AmphiMatrix formulation with Nitroglycerin (MQX-503) to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Disease, Scleroderma, Autoimmune Diseases
Keywords
Raynaud's
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topical AmphiMatrix with nitroglycerin (MQX-503)
Primary Outcome Measure Information:
Title
Reduction in Raynaud's Condition Score
Secondary Outcome Measure Information:
Title
Frequency and Severity of adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Outpatients, 18 years to 70 years.
Patients with a clinical diagnosis of Raynaud's phenomenon.
Patients who are willing to discontinue current vasodilator therapies.
Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud's phenomenon and its symptoms while participating in this study.
Negative pregnancy test in fertile women.
Patients who are able to give written informed consent and comply with all study requirements.
Exclusion Criteria:
Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
Patients who concurrently use any medication or device which might interfere with the study medication.
Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
Patients with a history of headaches.
Patients who have a history of an unstable medical problem.
Patients with cognitive or language difficulties.
Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
Patients who participated in a study of any investigational drug within four weeks prior to Visit 1.
Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal.
Patients who have had major surgery within six months of Visit 1.
Patients with interfering skin conditions.
Pregnant or nursing women.
Facility Information:
Facility Name
Standford Medical School
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
221 185
Country
Sweden
Facility Name
Royal National Hospital for Rheumatic Diseases
City
Bath
ZIP/Postal Code
LX1 3EX
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
University of Leeds
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QH
Country
United Kingdom
Facility Name
Hope Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
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