Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon

This study has been completed.
Sponsor:
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00419419
First received: January 4, 2007
Last updated: May 29, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Raynaud's Disease
Scleroderma
Autoimmune Diseases
Drug: Topical AmphiMatrix with nitroglycerin (MQX-503)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MediQuest Therapeutics:

Primary Outcome Measures:
  • Reduction in Raynaud's Condition Score

Secondary Outcome Measures:
  • Frequency and Severity of adverse events

Estimated Enrollment: 80
Study Start Date: December 2006
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419419

Locations
United States, California
Standford Medical School
Stanford, California, United States, 94305
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, New York
The Center for Rheumatology
Albany, New York, United States, 12206
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sweden
Lund University Hospital
Lund, Sweden, 221 185
United Kingdom
Royal National Hospital for Rheumatic Diseases
Bath, United Kingdom, LX1 3EX
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
University of Leeds
Leeds, United Kingdom, LS7 4SA
Royal Free Hospital
London, United Kingdom, NW3 2QH
Hope Hospital
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
MediQuest Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00419419     History of Changes
Other Study ID Numbers: 06-005
Study First Received: January 4, 2007
Last Updated: May 29, 2007
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by MediQuest Therapeutics:
Raynaud's

Additional relevant MeSH terms:
Raynaud Disease
Autoimmune Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Immune System Diseases
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014