Antistax® in Patients With Chronic Venous Insufficiency

Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191280
• Other study ID #: 1138.2
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2014
• Last updated: July 15, 2014
• Start date: April 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. primary completion date: September 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Drug:
• Antistax®, low dose

• Antistax®, high dose

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline of limb volume	determined by water displacement	Baseline, day 84	No
Secondary	Changes of limb volume	determined by water displacement	Baseline, days 42 and 98	No
Secondary	Measurement of calf circumference	in centimeters	Baseline, days 42, 84 and 98	No
Secondary	Measurement of ankle circumference	in centimeters	Baseline, days 42, 84 and 98	No
Secondary	Assessment of subjective symptoms on a visual analogue scale (VAS)		Baseline, days 42, 84 and 98	No
Secondary	Assessment of global efficacy by patient on a 4-point verbal rating scale		days 42, 84 and 98	No
Secondary	Assessment of global efficacy by investigator on a 4-point verbal rating scale		days 42, 84 and 98	No
Secondary	Assessment of global tolerability by patient on a 4-point verbal rating scale		days 42, 84 and 98	No
Secondary	Assessment of global tolerability by investigator on a 4-point verbal rating scale		days 42, 84 and 98	No
Secondary	Number of patients with adverse events		up to 14 weeks	No

External Links

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