Clinical trial NCT02184234: Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)
Official title: A 6-week, Open, Multicentre Safety Trial to Evaluate the Tolerability Profile of Antistax® Film Coated Tablets (Extr. Vitis Viniferae Siccum), 360 mg/Day Per os, in Male and Female Patients Suffering From Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Insufficiency
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 65
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number and intensity of serious and non-serious Adverse Events
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Global tolerability assessment by the patient and investigator
timeFrame: after 42 days of treatment
measure: Vital sign parameters (blood pressure and pulse rate)
timeFrame: at screening and after 6 weeks
measure: Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)
timeFrame: Baseline and after 6 weeks
measure: Global assessment of efficacy by the patient and investigator
timeFrame: after 6 weeks
Other outcomes:
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