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

May 29, 2007 updated by: MediQuest Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in Raynaud's Condition Score

Secondary Outcome Measures

Outcome Measure
Frequency and Severity of adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediQuest Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (ESTIMATE)

January 8, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2007

Last Update Submitted That Met QC Criteria

May 29, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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