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

NCT02683408 | Completed

• 1 other identifier: PVR-02
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Raynaud's Disease

Outcome Measures

Primary Outcomes (1)

• percentage of subjects with by at least 50% reduction in number of vasospastic episodes

  For each primary and secondary endpoint, the number and percentage of subjects meeting the criterion will be presented by treatment group at Week 4 and Week 8.

  8 weeks

Secondary Outcomes (1)

• percentage of subjects with at least 50% reduction in severity of vasospastic episodes

  8 eeks

Study Arms (2)

diosmiplex

EXPERIMENTAL

diosmiplex 630 mg BID administered orally

Dietary Supplement: diosmiplex

placebo

PLACEBO COMPARATOR

placebo BID administrered orally

Other: placebo

Interventions

placebo OTHER

inactive placebo

placebo

diosmiplex DIETARY_SUPPLEMENT

diosmiplex is an FDA regulated medical food product

Also known as: Vasculera

diosmiplex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Primus Pharmaceuticals: lead

Study Sites (11)

Sun Valley Arthritis Center

Peoria, Arizona, 85381, United States

Location

Advanced Arthritis Care and Research

Scottsdale, Arizona, 85258, United States

Location

Valerius Medical Group

Los Alamitos, California, 90720, United States

Location

Science and Research Institute, Inc.

Jupiter, Florida, 33458, United States

Location

Jeffrey Alper, MD

Naples, Florida, 34102, United States

Location

Steven Kimmel MD

Tamarac, Florida, 33321, United States

Location

Diagnostic Rheumatology

Indianapolis, Indiana, 46227, United States

Location

Arthritis Treatment Center

Frederick, Maryland, 21702, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

West Virginai Research Institute

Charleston, West Virginia, 25309, United States

Location

MeSH Terms

Conditions

Raynaud Disease

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Levy, MD

  Primus Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 17, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)