Raynaud's DiseaseNCT02683408
Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon
A study testing diosmiplex in people with Raynaud's Disease, run by Primus Pharmaceuticals at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Raynaud's Disease
- What is being tested?
- diosmiplex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
West Virginai Research Institute
Charleston, West Virginia, 25309
Henry Ford Hospital
Detroit, Michigan, 48202
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Arthritis Treatment Center
Frederick, Maryland, 21702
Diagnostic Rheumatology
Indianapolis, Indiana, 46227
Science and Research Institute, Inc.
Jupiter, Florida, 33458
Valerius Medical Group
Los Alamitos, California, 90720
Jeffrey Alper, MD
Naples, Florida, 34102
Sun Valley Arthritis Center
Peoria, Arizona, 85381
Advanced Arthritis Care and Research
Scottsdale, Arizona, 85258
Steven Kimmel MD
Tamarac, Florida, 33321
About this study
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.
Read the 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
- Conditions
- Raynaud's Disease
- Being tested
- placebo, diosmiplex
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
inactive placebo
diosmiplexDietary supplement
Also called Vasculera
diosmiplex is an FDA regulated medical food product
| Study group | Role | What they receive |
|---|---|---|
| diosmiplex | Experimental | diosmiplex 630 mg BID administered orally Receives: Dietary Supplement: diosmiplex |
| placebo | Placebo comparator | placebo BID administrered orally Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
percentage of subjects with at least 50% reduction in severity 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.
Measured: 8 eeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Levy, MD, Study director, Primus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683408
- Sponsor's protocol ID
- PVR-02
- Status last verified
- Aug 2017
- First submitted
- 12 Feb 2016
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT02683408
- Acronym / sponsor ID
- PVR-02
- Conditions
- Raynaud's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diosmiplex | Experimental | Dietary Supplement: diosmiplexdiosmiplex 630 mg BID administered orally |
| placebo | Placebo comparator | Other: placeboplacebo BID administrered orally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboinactive placebo | Other | placebo |
| diosmiplexAlso: Vasculeradiosmiplex is an FDA regulated medical food product | Dietary supplement | diosmiplex |
Primary outcome
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.
1 secondary outcome
percentage of subjects with at least 50% reduction in severity of vasospastic episodes
Time frame: 8 eeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Levy, MD study director
Primus Pharmaceuticals
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diosmiplex in people with Raynaud's Disease, run by Primus Pharmaceuticals at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of subjects with by at least 50% reduction in number of vasospastic episodes (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.