Antistax® in Patients With Chronic Venous Insufficiency

Phase 2

Completed

• Conditions: Venous Insufficiency
• Interventions: Drug: Antistax®, high dose; Drug: Placebo; Drug: Antistax®, low dose

• Registration Number: NCT02191280
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Primary Completion: 1998-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Study First Posted: 2014-07-16
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antistax®, high dose	Antistax®, high dose	-
Placebo	Placebo	-
Antistax®, low dose	Antistax®, low dose	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline of limb volume	Baseline, day 84	determined by water displacement

Secondary Outcome Measures

Name	Time	Method
Measurement of ankle circumference	Baseline, days 42, 84 and 98	in centimeters
Changes of limb volume	Baseline, days 42 and 98	determined by water displacement
Measurement of calf circumference	Baseline, days 42, 84 and 98	in centimeters
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