Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon

May 29, 2007 updated by: MediQuest Therapeutics

Phase II Dose Response 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 the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Purpose of this clinical study is to determine, in a controlled fashion, the response to two dosage strengths of a topical gel formulation of Nitroglycerin, MQX-503, in the determination of changes in finger blood flow and skin temperature in the fingers of patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma. The dosage strength response in the treatment of the symptoms (pain, tingling, numbness) will also be monitored.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

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
    • Washington
      • Renton, Washington, United States, 98055
        • Rainier Clinical Research

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients, 18 to 75 years
  • Clinical Diagnosis of Raynaud's, or observed event by study physician, or symptoms with reduced blood flow as meausred using laser doppler equipment
  • Agree to have test gels applied to finger
  • Discontinue current vasodialator therapeis for Raynaud's treatment
  • Four weeks from last clinical trial participation
  • Agree not to use any other investigational medications or therapies to treat Raynaud's and its symptoms while participating in this study including other dosages or forms of nitroglycerin, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, and verapamil
  • Negative pregnancy test for women prior to study start and agree to use effective contraception throughout
  • Must be able to give written informed consent and comply with all study requirements

Exclusion Criteria:

  • Concurrent use of any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction
  • Patients who have a known allergy to Nitroglycerin or common topical gel ingredients
  • Patients with a history of migraine, cluster or vascular headaches, or those who suffer from chronic pain
  • Patients with a history of an unstable medical problem or any current condition that would interfere in participation in the study
  • Patients unable to complete pain assessment instructions
  • Patients who in the last three months have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension
  • Patients who have participated in another investigational drug study within four weeks of the first study treatment
  • Patients with out of range laboratory screening values
  • Patients who have had major abdominal, thoracic or vascular surgery within six months of the first study treatment
  • Patients with open lesions or skin conditions where gel is to be applied
  • Pregnant or nursing women
  • Women who will not agree to comply with contraceptive requirements
  • Patients with a history of poor compliance, poor cooperation or unreliability

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure the time required for blood flow to return to baseline after cold exposure

Secondary Outcome Measures

Outcome Measure
Measure the time required for skin temperature to return to baseline after cold exposure
Prevention or reduction of symptoms following cold exposure.

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

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (Estimate)

September 20, 2006

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

  • 06-001

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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