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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683408
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Primus Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 12, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date August 17, 2017
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
percentage of subjects with by at least 50% reduction in number of vasospastic episodes [ Time Frame: 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
percentage of subjects with by at least 50% reduction in number of vasospastic episodes [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
percentage of subjects with at least 50% reduction in severity of vasospastic episodes [ Time Frame: 8 eeks ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
percentage of subjects with at least 50% reduction in severity of vasospastic episodes [ Time Frame: 8 eeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon
Official Title  ICMJE Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon
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.
Detailed Description

Raynaud's phenomenon is a disorder characterized by spasm of digital arteries leading to blanching, coldness and discomfort of the affected digit, affecting up to 3-5% of the population at some time in their lives. Raynaud's is roughly classified into primary and secondary forms. The primary form may occur without apparent cause or following such things as acute trauma, repetitive vibrating trauma or frostbite. Secondary Raynaud's occurs in association with a variety of systemic immunological diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SS) and Sjogren's syndrome. Perhaps the most severe forms are associated with systemic sclerosis, less often in SLE where severe microvascular changes can lead to digital ulcerations which are difficult to heal and produce considerable functional impairment Treatment of Raynaud's has been a significant clinical challenge. The primary modality is to avoid cold exposure. Many drug classes have been shown to have some, but highly variable and potential toxicities.

Diosmiplex is a prescription medical food product composed of the botanical based flavonoid molecule, diosmin, and a proprietary systemic blood alkalinizing agent, Alka4-complex. Diosmin has been used successfully in Europe as a drug for chronic venous insufficiency and its complications, including venous ulcers for more than 35 years. There is a large body of published literature regarding the molecular activity, clinical efficacy and safety of the active molecule in diosmin as well as its effects on the microvasculature where it has been shown to reduce inflammation, improve structural integrity, reduce capillary damage and improve capillary flow but no prospective clinical studies have been published regarding its effect in Raynaud's phenomenon. This will be the first prospective study to examine the efficacy and safety of diosmin, as diosmiplex, in both primary and secondary Raynaud's. The study will intentionally seek to enroll a subset of subjects with scleroderma with Raynaud's complicated by digital ulcers.

This will be a two (2) month randomized, double blind, placebo controlled study. Patients with either primary or secondary Raynaud's phenomenon present for at least 12 months and either untreated or inadequately controlled on therapy, defined as having at least four (4) vasospastic episodes/week, will be eligible for enrollment

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Raynaud's Disease
Intervention  ICMJE
  • Other: placebo
    inactive placebo
  • Dietary Supplement: diosmiplex
    diosmiplex is an FDA regulated medical food product
    Other Name: Vasculera
Study Arms  ICMJE
  • Experimental: diosmiplex
    diosmiplex 630 mg BID administered orally
    Intervention: Dietary Supplement: diosmiplex
  • Placebo Comparator: placebo
    placebo BID administrered orally
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2017)
87
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2016)
110
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683408
Other Study ID Numbers  ICMJE PVR-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Primus Pharmaceuticals
Study Sponsor  ICMJE Primus Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Levy, MD Primus Pharmaceuticals
PRS Account Primus Pharmaceuticals
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP