Lab Study of MQX-503 in Treatment of Raynaud's (NCT00253331) | Clinical Trial Compass
CompletedPhase 2/3
Lab Study of MQX-503 in Treatment of Raynaud's
United States36 participantsStarted 2004-11
Plain-language summary
The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.
Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours.
Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* clinical diagnosis of Raynaud's phenomenon
* outpoatients
* agree to apply gel as per protocol
* willing to discontinue current vasodilator therapy
* agree to stop other investigational medication for Raynaud's
* negative pregnancy test is fertile females
* able to give written informed consent and comply with study requirements
Exclusion Criteria:
* current use of ay nitrate medication or medications that interact with nitroglycerin
* patients with a known allergy to nitroglycerin or topical gel ingredients
* patients with a history of migraine headaches
* patients with unstable medical problems
* patients with cognitive or language difficulties
* patients with screening lab values more than 20% outside of normal
* patients with open lesions at site of application
* women of child-bearing potential who are unwilling to comply with contraceptive requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differntial time for blood flow to return to baseline following cold exposure.