Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Outpatients, 18 years to 70 years.
2.Patients with a clinical diagnosis of Raynaud’s phenomenon as determined by a history of cold sensitivity with pallor or cyanosis of the digits or an observed event by the study physician and have a history of at least two Raynaud’s events daily during a typical winter day.
3.Patients who agree to apply the test gels to their fingers as specified in the protocol.
4.Patients who are willing to discontinue current vasodilator therapies two weeks prior to Visit 1
5.Patients who have recently participated in a clinical trial and are willing to wait four weeks prior to Visit 1.
6.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. Such medications include: other dosages forms of nitroglycerin, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, and verapamil.
7.Negative pregnancy test in fertile women prior to the first study treatment and who agree to use effective contraception throughout the study
8.Patients who are able to give written informed consent and comply with all study requirements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction.
2.Patients who concurrently use any medication which might interfere with the study medication, specifically calcium channel blockers and the compounds listed above in prohibited concomitant medications.
3.Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
4.Patients with a history of migraine, cluster or vascular headaches, chronic pain (defined as pain of three hour duration or longer on a daily basis) with greater intensity than the pain associated with Raynaud’s phenomenon or other chronic pain condition in their fingers.
5.Patients who have a history of an unstable medical problem or any current medical condition that, in the judgment of the investigator, would contraindicate the administration of the study medication, interfere with the study evaluations, or interfere with the patient’s ability to comply with the study protocol.
6.Patients with cognitive or language difficulties that would impair completion of the pain assessment instruments.
7.Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension (defined as patients not being treated medically to control these conditions).
8.Patients who participated in a study of any investigational drug within four weeks prior to Visit 1.
9.Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal or which are considered to be clinically significant to the investigator.
10.Patients who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
11.Patients with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where the gel is to be applied.
12.Pregnant or nursing women.
13.Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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