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

Raynaud's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378521
• Other study ID #: 06-001
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2006
• Last updated: May 29, 2007
• Start date: July 2006
• Est. completion date: July 2006

Study information

• Verified date: May 2007
• Source: MediQuest Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2006
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Diseases
• Neoplasm Metastasis
• Raynaud Disease
• Raynaud's Disease
• Raynaud's Disease Secondary to Autoimmune Disease
• Raynaud's Disease Secondary to Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

Drug:
• MQX-503

Locations

Country	Name	City	State
United States	Rainier Clinical Research	Renton	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MediQuest Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the time required for blood flow to return to baseline after cold exposure
Secondary	Measure the time required for skin temperature to return to baseline after cold exposure
Secondary	Prevention or reduction of symptoms following cold exposure.