Patients diagnosed with primary chronic vein disease MedDRA version: 20.0 Level: LLT Classification code 10066682 Term: Chronic venous insufficiency System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Flebaven®
Product Name: Flebaven
Pharmaceutical Form: Tablet
Sponsors
Krka, d.d., Novo mesto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 20 to 70 years. - Patients diagnosed with primary chronic venous disease - Patients whose average leg pain is greater than or equal to 4 on the numerical scale (NS), which corresponds to the pain of moderate or severe intensity. - Patients classified on the most affected foot by the CEAP (Comprehensive Classification System for Chronic Venous Disorders) classification in the clinical grade C0s to C4s *. - Patients with a potential exclusion of another cause of leg pain (in the case of a discrepancy between the patient's subjective assessment of the severity of the symptoms and the physician's grade according to CEAP). - A Statement of Conscious and Free Consent signed. - Patient's ability to participate in a clinical trial. * 0-no visible or palpable signs of a venous illness; 1-teleangiectasia or reticular veins; 2-spine veins (varices); 3-swelling; 4-skin changes (hyperpigmentation, dermatitis, lipodermatosclerosis) 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 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Hypersensitivity to the active substance or to any of the excipients in the test product. • Patients classified on the most affected foot by the CEAP (Comprehensive Classification System for Chronic Venous Disorders) classification in the clinical grade C5s to C6s *. • Patients with concomitant nepharmacological treatment (sclerotherapy, surgical treatment of varicose veins, angioplasty, endovascular device) or patients with nepharmacological treatment within three months prior to inclusion. • Lower limb lymphaden, renal failure or decompensated cardiac failure, liver failure, gastrointestinal resection history, insufficient nutrition, malabsorption, active venous thrombosis, and significant chronic deep vein obstruction leading to venous claddication and important compression therapy, severe inflammatory disease, and others causes of lower limb pain. • Patients with concomitant treatment containing anti-inflammatory drugs (other than acetylsalicylic acid at an antiaggregation dose of less than 350 mg daily), systemic corticosteroids, immunosuppressive agents, and venoactive drugs. • Patients with concomitant treatment with opiates that were introduced or modified during the month prior to enrollment in the study. • Pregnant or nursing patients. • Patients who have recently given birth (6 months or less prior to inclusion). • Patients who, according to the researcher, will not be eligible for treatment. * 5-skin changes (hyperpigmentation, dermatitis, lipodermatosclerosis) and hepatic venous ulceration; 6 skin changes (hyperpigmentation, dermatitis, lipodermatosclerosis) and active venous ulcer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to confirm the safety and efficacy of Flebaven 1000 mg once daily on: - reduction of leg pain, - reduction the feeling of heavy legs, - reduction of swelling of the legs and - improving the quality of life. ;Secondary Objective: Not applicable;Primary end point(s): Percentage of patients in whom foot pain decreased by = 30% (estimated on the numerical scale (NS) or the percentage of patients whose assessment of pain to NS did not exceed grade 3 ;Timepoint(s) of evaluation of this end point: [Timeframe: starting point, after 4 weeks, after 12 weeks]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Compare the difference in foot pain intensity from beginning to end of the study, estimated at NS [Timeframe: starting point, after 4 weeks, after 12 weeks]. - Compare the difference in the feeling of difficulty from the beginning to the end of the study, estimated at NS [Time frame: starting point, after 4 weeks, after 12 weeks]. - Compare the difference in the swelling intensity of the feet from the beginning to the end of the study, estimated at NS [Time frame: starting point, after 4 weeks, after 12 weeks]. - Compare the difference in quality of life from the beginning to the end of the study, estimated using the SF-20 questionnaire (Quality of Life Questionnaire) [Timeframe: starting point, after 12 weeks]. - Compare the difference in the severity of the disease during treatment based on the clinical global disease severity indicator (CGI-S) [Timeframe: starting point, after 4 weeks, after 12 weeks]. - Comparison of the difference in the severity of the disease during treatment based on the clinical global disease improvement indicator (CGI-I) [Timeframe: after 4 weeks, after 12 weeks]. - Subgroup of 25 patients: compare the difference in CVD visual signs (presence of varicose veins, swelling) from beginning to end treatment based on analysis of photos in patients with visible signs of KVB. [Timeframe: starting point, after 12 weeks].;Timepoint(s) of evaluation of this end point: starting point, after 4 weeks, after 12 weeks | — |
Countries
Slovenia
Contacts
Public ContactClinical Trials Information
Krka d.d., Novo mesto
Outcome results
None listed