Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon

Inclusion Criteria:

• Outpatients, 18 years to 70 years.
• Patients with a clinical diagnosis of Raynaud’s phenomenon.
• Patients who are willing to discontinue current vasodilator therapies.
• Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud’s phenomenon and its symptoms while participating in this study.
• Negative pregnancy test in fertile women.
• Patients who are able to give written informed consent and comply with all study requirements.

Exclusion Criteria:

• Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
• Patients who concurrently use any medication or device which might interfere with the study medication.
• Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
• Patients with a history of headaches.
• Patients who have a history of an unstable medical problem.
• Patients with cognitive or language difficulties.
• Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
• Patients who participated in a study of any investigational drug within four weeks prior to Visit 1.
• Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal.
• Patients who have had major surgery within six months of Visit 1.
• Patients with interfering skin conditions.
• Pregnant or nursing women.