Status:
COMPLETED
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
Lead Sponsor:
MediQuest Therapeutics
Conditions:
Raynaud's Disease
Scleroderma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 t...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00419419
Start Date
December 1 2006
Last Update
May 30 2007
Active Locations (12)
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1
Standford Medical School
Stanford, California, United States, 94305
2
University of Connecticut
Farmington, Connecticut, United States, 06030
3
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
4
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224