Antistax® in Patients With Chronic Venous Insufficiency

The Ability of Antistax® to Improve Chronic Venous Insufficiency (CVI) I and II in Male and Female Patients: a Dose Response Study

Study to determine the efficacy and tolerability of two dose levels of Antistax relative to placebo in patients suffering from CVI grade I or incipient grade II

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency
• Intervention / Treatment: Drug: Placebo; Drug: Antistax®, low dose; Drug: Antistax®, high dose

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female
• Between 25 and 75 years of age
• CVI I or CVI II (without expanded trophic disturbances)
• Willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

Concomitant disease(s) exclusion criteria:

• Decompensated cardiac insufficiency
• Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, etc)
• Peripheral arterial disease (ankle/arm pressure index < 0.9)
• Current acute phlebitis or thrombosis
• Renal insufficiency (Serum creatinine > 1.5 mg/dl)
• Liver disease (SGPT (ALAT) > 3x upper limit of normal)
• Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies
• Anamnestic indications of diabetic microangiopathy or polyneuropathy
• Drug and/or alcohol abuse
• Severe climacteric complaints
• Immobility
• Avalvulia
• Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
• State after pulmonary embolism
• Recognized hypersensitivity to the trial drug ingredients
• Current florid venous ulcus
• Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc.

Previous treatment(s) exclusion criteria:

• Treatment with venous drugs within the last 4 weeks
• Treatment with laxatives which affect fluid or electrolyte balance within the last 8 days
• Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days
• Changes in post-menopausal Hormone replacement within the last 2 months

Concomitant treatment/non-drug therapy exclusion criteria:

• Other venous drugs apart from the trial medication
• Compression therapy
• Venous surgery at the leg(s)
• Extensive use (on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance
• Major surgery requiring full anesthesia

Other exclusion criteria:

• Previously studied under this protocol
• Participation in another clinical trial within the previous 90 days or during the present study
• Patients who have visited a sauna or had other thermal applications in the previous day before any visit
• Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
• Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial
• Patients in a bad general health state according to the investigator's judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Antistax®, low dose	Drug: Antistax®, low dose
Experimental: Antistax®, high dose	Drug: Antistax®, high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline of limb volume	determined by water displacement	Baseline, day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of limb volume	determined by water displacement	Baseline, days 42 and 98
Measurement of calf circumference	in centimeters	Baseline, days 42, 84 and 98
Measurement of ankle circumference	in centimeters	Baseline, days 42, 84 and 98
Assessment of subjective symptoms on a visual analogue scale (VAS)		Baseline, days 42, 84 and 98
Assessment of global efficacy by patient on a 4-point verbal rating scale		days 42, 84 and 98
Assessment of global efficacy by investigator on a 4-point verbal rating scale		days 42, 84 and 98
Assessment of global tolerability by patient on a 4-point verbal rating scale		days 42, 84 and 98
Assessment of global tolerability by investigator on a 4-point verbal rating scale		days 42, 84 and 98
Number of patients with adverse events		up to 14 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1998
• Primary Completion (Actual): September 1, 1998

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Quercetin
• Other Study ID Numbers: 1138.2