Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon (NCT02683408) | Clinical Trial Compass
CompletedNot Applicable
Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon
United States87 participantsStarted 2016-02
Plain-language summary
Diosmiplex is a product marketed for the management of diseases due to venous and microvascular dysfunction. Raynaud's phenomenon is a disorder of characterized by spasm of small arteries and impaired microvascular flow. This study will examine the effects of diosmiplex on the frequency and severity of Raynaud's episodes in susceptible people.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* either gender, ages 18-80
* established diagnosis of primary or secondary Raynaud's phenomenon
* minimum of 4 vasospastic episodes/week
* medication specifically for Raynaud's must be stable for 30 days prior to the screening visit and must be maintained unchanged for the duration of the study medication specifically for digital ulceration must be stable for 60 days prior to the screening visit and must be maintained unchanged for the duration of the study
* not pregnant or breast feeding
* using approved method of birth control if capable of becoming pregnant (Appendix II)
* capable of reading and understanding the informed consent document
Exclusion Criteria:
* pregnant or nursing women
* any change in dose of oral medication specifically for Raynaud's or digital ulcers including, but not limited to, vasodilators, adrenergic blockers, antihypertensives, calcium channel blockers, ACE inhibitors, phosphodiesterase inhibitors (e.g., sildenofil,) endothelin receptor antagonists (e.g., bosentan), prostanoids (e.g., iloprost) within the 30 days prior to the screening visit for Raynaud's and /or 60 days for digital ulcers and during the duration of the study.
* any intravenous or intra-arterial Raynaud's therapy within 1 month prior to the screening visit
* Raynaud's secondary to mechanical (non-thermal) trauma
* concomitant use of diclofenac or metronidazole
* history of unstable coronary artery disease, chronic hepatic disease with ALT, AST, or alkaline …
What they're measuring
1
percentage of subjects with by at least 50% reduction in number of vasospastic episodes