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

NCT00378521 | Completed Phase 2

• 1 other identifier: 06-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

• Prevention or reduction of symptoms following cold exposure.

Interventions

MQX-503 DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MediQuest Therapeutics: lead

Study Sites (1)

Rainier Clinical Research

Renton, Washington, 98055, United States

Location

MeSH Terms

Conditions

Raynaud Disease; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Connective Tissue Diseases

Study Officials

• Leslie Klaff, MD

  Rainier Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 18, 2006
• First Posted: September 20, 2006
• Study Start: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: May 30, 2007

Record last verified: 2007-05

Locations

US (1)