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

Autoimmune Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419419
• Other study ID #: 06-005
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2007
• Last updated: May 29, 2007
• Start date: December 2006

Study information

• Verified date: May 2007
• Source: MediQuest Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Raynaud Disease
• Raynaud's Disease
• Scleroderma

Intervention

Drug:
• Topical AmphiMatrix with nitroglycerin (MQX-503)

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund
United Kingdom	Royal National Hospital for Rheumatic Diseases	Bath
United Kingdom	Ninewells Hospital and Medical School	Dundee
United Kingdom	University of Leeds	Leeds
United Kingdom	Royal Free Hospital	London
United Kingdom	Hope Hospital	Salford
United States	The Center for Rheumatology	Albany	New York
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Duke University	Durham	North Carolina
United States	University of Connecticut	Farmington	Connecticut
United States	Standford Medical School	Stanford	California
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
MediQuest Therapeutics

Countries where clinical trial is conducted

United States,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Raynaud's Condition Score
Secondary	Frequency and Severity of adverse events