Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From Chronic Venous Insufficiency

Venous Insufficiency Clinical Trial

Official title:

A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax® Film Coated Tablets, 360 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191254
• Other study ID #: 1138.4
• Status: Completed
• Phase: Phase 3
• First received: July 15, 2014
• Last updated: July 15, 2014
• Start date: April 2004

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 DevicesAustria: Federal Ministry for Health and WomenCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location, Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• 18 years of age or older

• CVI, Clinical Class 3 (oedema) or 4a (mild skin changes ascribed to venous disease, e.g. pigmentation), according to the CEAP classification

• Willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

Concomitant diseases:

• Decompensated cardiac insufficiency

• Oedema not due to venous disease of the legs (e.g., latent cardiac insufficiency, renal insufficiency, lymphoedema, 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 > 3x upper limit of normal)

• Other diseases: hyper- or hypocalcaemia, malignancies

• Anamnestic indications of diabetic microangiopathy or polyneuropathy

• Drug and/or alcohol abuse

• Severe climacteric complaints: changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months

• Immobility

• Avalvulia

• Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)

• State after pulmonary embolism

• Recognised hypersensitivity to the trial drug ingredients

• Current florid venous ulcus

• Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compression treatment, phlebectomy, etc.

Previous treatments:

• Patients who are on compression therapy and/or are wearing support stockings and who optimally benefit from these measures

• Treatment with venous drugs within the last 2 weeks prior to the intake of study medication

• Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors, calcium antagonists, or laxatives within the last 2 weeks prior to the intake of study medication

Concomitant treatment/non-drug therapy exclusion criteria:

• Other venous drugs apart from the trial medication

• Venous surgery or sclerotherapy within the last 12 month at the leg used for volumetry

• Extensive use of laxatives

• Major surgery requiring full anaesthesia

Other exclusion criteria:

• Previously studied under this protocol

• Participation in another clinical trial within the previous 90 days or during the present study

• Patient is investigator, co-investigator, or study nurse in this study

• 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 judgement

Study Design

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

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Drug:
• Antistax®

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in limb volume determination	water displacement method	Baseline, day 84	No
Secondary	Changes in limb volume determination	water displacement method	Baseline, day 21 and day 42	No
Secondary	Changes in the calf circumference	in centimeters	Baseline, at day 21, 42 and 84	No
Secondary	Changes in the ankle circumference	in centimeters	Baseline, at day 21, 42, and 84	No
Secondary	Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)		Baseline, at day 21, 42, and 84	No
Secondary	Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS)		day 84	No
Secondary	Global assessment of efficacy by the investigator on a 4-point VRS		day 84	No
Secondary	Global assessment of tolerability by the patient on a 4-point VRS		day 84	No
Secondary	Global assessment of tolerability by the investigator on a 4-point VRS		Day 84	No
Secondary	Number of patients with adverse events		up to 12 weeks	No
Secondary	Number of patients with clinically significant changes in laboratory values		Baseline, week 12	No
Secondary	Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))		Baseline, up to 12 weeks	No

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