Venous Insufficiency
Conditions
Brief summary
Main objective: Safety and tolerability of Antistax® film coated tablets Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of chronic venous insufficiency
Interventions
DRUGAntistax film coated tablets
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema * Male or female out-patients of any ethnic origin * Age ranging from 25 to 75 years
Exclusion criteria
* Known hypersensitivity to any ingredients of the study medication * Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances * Florid venous ulcers * Arterial occlusive disease, irrespective of the severity * Phlebitis or thrombophlebitis * Clinical indication for an acute phlebologic intervention, e.g., compressive treatment, phlebectomy, etc. * Evidence of diabetic micro-angiopathy or polyneuropathy in medical history * Poor general health (based on the investigator's judgement) * Addiction to alcohol abuse * Mental illness and inability (or limited ability) to work, or inability (or limited ability) to follow spoken or written explanations concerning the trial * Women of child-bearing age not using any reliable contraceptive methods * Pregnant or lactating women * Patients previously enrolled in the present study or participating in another clinical study, or who had taken part in another study within the previous 90 days * Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as heparin-containing preparations, sclerosing agents, or bioflavonoids other than the study medication) during the trial. Medications or measures for CVI had to be stopped 14 day prior to intake of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and intensity of serious and non-serious Adverse Events | up to 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Global tolerability assessment by the patient and investigator | after 42 days of treatment |
| Vital sign parameters (blood pressure and pulse rate) | at screening and after 6 weeks |
| Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS) | Baseline and after 6 weeks |
| Global assessment of efficacy by the patient and investigator | after 6 weeks |
Outcome results
None listed