Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon (NCT00266669) | Clinical Trial Compass
CompletedPhase 3
Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
United States, Canada200 participantsStarted 2005-12
Plain-language summary
The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma.
Who can participate
Age range
18 Years – 70 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
* 2 or more Raynaud's events on a typical winter day
* Agree to discontinue current treatments for Raynaud's
* Negative pregnancy test and agree to use effective contraception during study
Exclusion Criteria:
* Current use of nitrate medications or medications known to interact with nitroglycerin
* Patients who currently use medications, like calcium channel blockers, that might interfere with study medication
* Patients with a known allergy to nitroglycerin or common topical ingredients
* Patients with a history of migraine headaches
* Patients with a history of unstable medical problems
* Patients with cognitive or language difficulties that would impair completion of assessment instruments
* Patients with lab screening values more than 20% outside normal range
* Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening
* Pregnant or nursing women
* Women of child-bearing potential who are unwilling to comply with the 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
Improvements in Raynaud's Assessment Score comparing active to placebo
2
Reduction of number of Raynaud's events
3
Decrease in duration of Raynaud's events
4
Decrease in symptoms associated with Raynaud's
5
Assess safety: frequency and severity of adverse events associated with the study drug