Lab Study of MQX-503 in Treatment of Raynaud's

May 29, 2007 updated by: MediQuest Therapeutics

Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon

The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.

Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours.

Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

36

Phase

  • Phase 2
  • 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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical College

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of Raynaud's phenomenon
  • outpoatients
  • agree to apply gel as per protocol
  • willing to discontinue current vasodilator therapy
  • agree to stop other investigational medication for Raynaud's
  • negative pregnancy test is fertile females
  • able to give written informed consent and comply with study requirements

Exclusion Criteria:

  • current use of ay nitrate medication or medications that interact with nitroglycerin
  • patients with a known allergy to nitroglycerin or topical gel ingredients
  • patients with a history of migraine headaches
  • patients with unstable medical problems
  • patients with cognitive or language difficulties
  • patients with screening lab values more than 20% outside of normal
  • patients with open lesions at site of application
  • women of child-bearing potential who are unwilling to comply with contraceptive requirements.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Differntial time for blood flow to return to baseline following cold exposure.

Secondary Outcome Measures

Outcome Measure
Differential time for skin temperature to return to baseline following cold exposure.
Quantitative reduction or prevention in symptoms following cold exposure.

Collaborators and Investigators

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

Sponsor

MediQuest Therapeutics

Investigators

  • Principal Investigator: Laura K Hummers, MD, Johns Hopkins University
  • Principal Investigator: Carin Dugowson, MD, MPH, University of Washington Medical College

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

November 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

November 13, 2005

First Submitted That Met QC Criteria

November 13, 2005

First Posted (Estimate)

November 15, 2005

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

  • MQT 03-001

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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