Antistax® in Patients With Chronic Venous Insufficiency

NCT ID: NCT02191280

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-04-30

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

Conditions

Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Antistax®, low dose

Group Type: EXPERIMENTAL

Antistax®, low dose

Intervention Type: DRUG

Antistax®, high dose

Group Type: EXPERIMENTAL

Antistax®, high dose

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Antistax®, low dose

Intervention Type: DRUG

Antistax®, high dose

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

• 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

• 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

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 33141449 (View on PubMed)

Other Identifiers

1138.2

Identifier Type: -

Identifier Source: org_study_id