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

MediQuest Therapeutics

Status and phase

Completed

Phase 2

Conditions

Raynaud's Disease

Raynaud's Disease Secondary to Scleroderma

Raynaud's Disease Secondary to Autoimmune Disease

Treatments

Drug: MQX-503

Study type

Interventional

Funder types

Industry

Identifiers

NCT00378521

06-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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