Status:
COMPLETED
Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon
Lead Sponsor:
MediQuest Therapeutics
Conditions:
Raynaud's Disease
Raynaud's Disease Secondary to Scleroderma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Detailed 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 change...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00378521
Start Date
July 1 2006
End Date
July 1 2006
Last Update
May 30 2007
Active Locations (1)
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1
Rainier Clinical Research
Renton, Washington, United States, 98055