Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon

Completed · Not applicable · Has a placebo group

Conditions studied: Raynaud's Disease

In brief

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.

Key facts

Study ID

NCT02683408

Run by

Primus Pharmaceuticals

People needed

87

Starts

2016-02-01

Expected to finish

2017-07-01

Last updated by the study team

2017-08-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 phosphatase >1.3 time upper limit of normal for reference laboratory, renal disease with serum creatinine >2.5 or any gastrointestinal disease that could potentially interfere with absorption of the study product.
• history of substance abuse including "recreational drugs" and/or alcohol intake in excess of one unit daily. For the purposes of this study a unit of alcohol is defined as 12 ox. of beer, 6 oz. of wine or 1.5 oz. of hard liquor.
• history of any significant medical condition that, in the opinion of the investigator might put the subject at risk in this trial
• participation in another clinical trial within 30 days of the screening visit or 7 half lives of the study product, whichever is longer

Where it is running

• Sun Valley Arthritis Center — Peoria, Arizona, United States
• Advanced Arthritis Care and Research — Scottsdale, Arizona, United States
• Valerius Medical Group — Los Alamitos, California, United States
• Science and Research Institute, Inc. — Jupiter, Florida, United States
• Jeffrey Alper, MD — Naples, Florida, United States
• Steven Kimmel MD — Tamarac, Florida, United States
• Diagnostic Rheumatology — Indianapolis, Indiana, United States
• Arthritis Treatment Center — Frederick, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• West Virginai Research Institute — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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