Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
Information source: MediQuest Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Raynaud's Disease; Scleroderma; Autoimmune Diseases
Intervention: Topical AmphiMatrix with nitroglycerin (MQX-503) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: MediQuest Therapeutics
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Reduction in Raynaud's Condition Score
Secondary outcome: Frequency and Severity of adverse events
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Lund University Hospital, Lund 221 185, Sweden
Royal National Hospital for Rheumatic Diseases, Bath LX1 3EX, United Kingdom
Ninewells Hospital and Medical School, Dundee DD1 9SY, United Kingdom
University of Leeds, Leeds LS7 4SA, United Kingdom
Royal Free Hospital, London NW3 2QH, United Kingdom
Hope Hospital, Salford M6 8HD, United Kingdom
Standford Medical School, Stanford, California 94305, United States
University of Connecticut, Farmington, Connecticut 06030, United States
Georgetown University Medical Center, Washington, District of Columbia 20007, United States
Johns Hopkins Bayview Medical Center, Baltimore, Maryland 21224, United States
The Center for Rheumatology, Albany, New York 12206, United States
Duke University, Durham, North Carolina 27710, United States
Additional Information
Starting date: December 2006
Last updated: May 29, 2007
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