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

NCT ID: NCT00419419

Last Updated: 2007-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Raynaud's Disease Scleroderma Autoimmune Diseases

Keywords

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Raynaud's

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Topical AmphiMatrix with nitroglycerin (MQX-503)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MediQuest Therapeutics

INDUSTRY

Sponsor Role lead

Locations

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Standford Medical School

Stanford, California, United States

Site Status

University of Connecticut

Farmington, Connecticut, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

The Center for Rheumatology

Albany, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Lund University Hospital

Lund, , Sweden

Site Status

Royal National Hospital for Rheumatic Diseases

Bath, , United Kingdom

Site Status

Ninewells Hospital and Medical School

Dundee, , United Kingdom

Site Status

University of Leeds

Leeds, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Hope Hospital

Salford, , United Kingdom

Site Status

Countries

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United States Sweden United Kingdom

Other Identifiers

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06-005

Identifier Type: -

Identifier Source: org_study_id