Ignite Creation Date:
2024-05-06 @ 8:10 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02683408
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2016-02-12
Brief Title:
Diosmiplex Vasculera in Primary and Secondary Raynauds Phenomenon
Sponsor:
Primus Pharmaceuticals
Organization:
Primus Pharmaceuticals
Study Overview
Official Title:
Diosmiplex Vasculera in Primary and Secondary Raynauds Phenomenon
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diosmiplex is a product marketed for the management of diseases due to venous and microvascular dysfunction Raynauds 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 Raynauds episodes in susceptible people
Detailed Description:
Raynauds 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 Raynauds 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 Raynauds occurs in association with a variety of systemic immunological diseases such as rheumatoid arthritis RA systemic lupus erythematosus SLE systemic sclerosis SS and Sjogrens 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 Raynauds 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 Raynauds phenomenon This will be the first prospective study to examine the efficacy and safety of diosmin as diosmiplex in both primary and secondary Raynauds The study will intentionally seek to enroll a subset of subjects with scleroderma with Raynauds complicated by digital ulcers
This will be a two 2 month randomized double blind placebo controlled study Patients with either primary or secondary Raynauds phenomenon present for at least 12 months and either untreated or inadequately controlled on therapy defined as having at least four 4 vasospastic episodesweek will be eligible for enrollment
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 Raynauds phenomenon This will be the first prospective study to examine the efficacy and safety of diosmin as diosmiplex in both primary and secondary Raynauds The study will intentionally seek to enroll a subset of subjects with scleroderma with Raynauds complicated by digital ulcers
This will be a two 2 month randomized double blind placebo controlled study Patients with either primary or secondary Raynauds phenomenon present for at least 12 months and either untreated or inadequately controlled on therapy defined as having at least four 4 vasospastic episodesweek will be eligible for enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None