Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon (NCT00378521) | Clinical Trial Compass
CompletedPhase 2
Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon
United States15 participantsStarted 2006-07
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 …
What they're measuring
1
Measure the time required for blood flow to return to baseline after cold exposure