Raynaud's Disease
Conditions
Keywords
Raynaud's Phenomenon, Raynaud's Disease, Scleroderma, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease
Brief 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.
Interventions
Sponsors
MediQuest Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of number of Raynaud's events | — |
| Decrease in symptoms associated with Raynaud's | — |
| Assess safety: frequency and severity of adverse events associated with the study drug | — |
| Improvements in Raynaud's Assessment Score comparing active to placebo | — |
| Decrease in duration of Raynaud's events | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in emergence of digital ulcers for patients with scleroderma | — |
| Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions | — |
Countries
Canada, United States
Outcome results
None listed