patients with SVT of the lower limbs that have completed the acute phase treatment cycle
Conditions
Interventions
Trade Name: PRISMA
Product Name: Prisma
Product Code: [B01AB]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Mesoglicano
Current Sponsor code: B01AB
Other descriptive name: Mesoglican
Concent
Sponsors
MEDIOLANUM FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects of both sexes, aged> = 18 years 2. With previous diagnosis of SVT of the lower limbs documented with Eco-color-Doppler (CCDU), which was the debut of at least 5 cm extension and at least 3 cm from the saphenous junctions (magna saphenous vein and the small saphenous vein) 3. who have completed the initial course of therapy with fondaparinux 2.5 mg / day for 45 days, as required by the latest Lines International Guide (ACCP). 4. That the CCDU to screening do not present a concurrent involvement of the deep venous system, or an extension of the initial TVS Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 450
Exclusion criteria
Exclusion criteria: 1. Poor compliance to treatment of TVS, 2. life expectancy 4, 8. chronic lymphedema of the lower limbs, 9. recent ( 160mg / day, centrally acting analgesics, 13. individuals with hypersensitivity to mesoglycan, heparin or heparinoids, galactose intolerance or lactase deficiency, carriers of diseases and hemorrhagic diathesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the superiority of mesoglycan (Prisma), compared to placebo in reducing the incidence of complications thromboembolic (relapsed / extension TVS, DVT, PE) in patients who have completed the treatment phase of the cycle acute after a superficial vein thrombosis (SVT).;Secondary Objective: Cumulative occurrence of the first event between: recurrence or extension, asymptomatic or symptomatic, TVS, new proximal / distal DVT (asymptomatic or symptomatic), pulmonary embolism (fatal / nonfatal symptomatic); modification of the score rVCSS (effectiveness) and Veines / Sym-QOL (quality of life) in the treatment and in the following 12 months; recanalization of the affected vein primary thrombotic event; New development of deep venous reflux and / or surface; impact of elastic compression therapy; contribution to the levels of CRP in predicting the primary endpoint onset.;Primary end point(s): Cumulative occurrence of the first event, with instrumental confirmation, which occurred during the study treatment including: recurrence or extension, asymptomatic or symptomatic, TVS, new DVT (asymptomatic or symptomatic proximal / distal symptomatic isolated), pulmonary embolism (fatal / non-fatal symptomatic ).;Timepoint(s) of evaluation of this end point: During the treatment period in days: 30, 60, 135, 225, 315 (+ -5gg) after randomization, and in the period of follow-up at 3, 6 and 9 months after the end of treatment and then every 6 months until the end of the study, subjects will be contacted by telephone by staff trained to assess their compliance with treatment, the possible use of drugs not allowed and the occurrence of adverse events and / or end-points of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cumulative occurrence of the first event between: recurrence or extension, asymptomatic or symptomatic, TVS, new proximal / distal DVT (asymptomatic or symptomatic), pulmonary embolism (fatal / nonfatal symptomatic); modification of the score rVCSS (effectiveness) and Veines / Sym-QOL (quality of life) in the treatment and in the following12 months; recanalization of the affected vein primary thrombotic event; New development of deep venous reflux and / or surface; impact of elastic compression therapy; contribution to the levels of CRP in predicting the primary endpoint onset.;Timepoint(s) of evaluation of this end point: During the treatment period in days: 30, 60, 135, 225, 315 (+ -5gg) after randomization, and in the period of follow-up at 3, 6 and 9 months after the end of treatment and then every 6 months until the end of the study, subjects will be contacted by telephone by staff trained to assess their compliance with treatment, the possible use of drugs not allowed and the occurrence of adverse events and / or end-points of the study | — |
Countries
Italy
Contacts
Public ContactNicoletta Iori
Mediolanum Farmaceutici s.p.a.
Outcome results
None listed