Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)

Venous Insufficiency Clinical Trial

Official title:

A 6-week, Open, Multicentre Safety Trial to Evaluate the Tolerability Profile of Antistax® Film Coated Tablets (Extr. Vitis Viniferae Siccum), 360 mg/Day Per os, in Male and Female Patients Suffering From Chronic Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184234
• Other study ID #: 1138.5
• Status: Completed
• Phase: Phase 4
• First received: July 2, 2014
• Last updated: July 11, 2014
• Start date: June 2001

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial Summary

Main objective: Safety and tolerability of Antistax® film coated tablets

Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of chronic venous insufficiency

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema

• Male or female out-patients of any ethnic origin

• Age ranging from 25 to 75 years

Exclusion Criteria:

• Known hypersensitivity to any ingredients of the study medication

• Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances

• Florid venous ulcers

• Arterial occlusive disease, irrespective of the severity

• Phlebitis or thrombophlebitis

• Clinical indication for an acute phlebologic intervention, e.g., compressive treatment, phlebectomy, etc.

• Evidence of diabetic micro-angiopathy or polyneuropathy in medical history

• Poor general health (based on the investigator's judgement)

• Addiction to alcohol abuse

• Mental illness and inability (or limited ability) to work, or inability (or limited ability) to follow spoken or written explanations concerning the trial

• Women of child-bearing age not using any reliable contraceptive methods

• Pregnant or lactating women

• Patients previously enrolled in the present study or participating in another clinical study, or who had taken part in another study within the previous 90 days

• Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as heparin-containing preparations, sclerosing agents, or bioflavonoids other than the study medication) during the trial. Medications or measures for CVI had to be stopped 14 day prior to intake of study medication.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Drug:
• Antistax film coated tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and intensity of serious and non-serious Adverse Events		up to 6 weeks	No
Secondary	Global tolerability assessment by the patient and investigator		after 42 days of treatment	No
Secondary	Vital sign parameters (blood pressure and pulse rate)		at screening and after 6 weeks	No
Secondary	Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)		Baseline and after 6 weeks	No
Secondary	Global assessment of efficacy by the patient and investigator		after 6 weeks	No

External Links

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