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

Primary Purpose

Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Autoimmune Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

MQX-503

About this trial

This is an interventional treatment trial for Raynaud's Disease focused on measuring Raynaud's, Nitroglycerin, topical gel, cold hands, painful hands, scleroderma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

Rainier Clinical Research

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measure the time required for skin temperature to return to baseline after cold exposure

Prevention or reduction of symptoms following cold exposure.

Full Information

NCT ID

NCT00378521

First Posted

September 18, 2006

Last Updated

May 29, 2007

Sponsor

MediQuest Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00378521

Brief Title

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

Official Title

Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

MediQuest Therapeutics

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Autoimmune Disease

Keywords

Raynaud's, Nitroglycerin, topical gel, cold hands, painful hands, scleroderma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

MQX-503

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Measure the time required for skin temperature to return to baseline after cold exposure

Title

Prevention or reduction of symptoms following cold exposure.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leslie Klaff, MD

Organizational Affiliation

Rainier Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rainier Clinical Research

City

Renton

State/Province

Washington

ZIP/Postal Code

98055

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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