Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)
Primary Purpose
Venous Insufficiency
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Antistax film coated tablets
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antistax film coated tablets
Arm Description
Outcomes
Primary Outcome Measures
Number and intensity of serious and non-serious Adverse Events
Secondary Outcome Measures
Global tolerability assessment by the patient and investigator
Vital sign parameters (blood pressure and pulse rate)
Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)
Global assessment of efficacy by the patient and investigator
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02184234
Brief Title
Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
October 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antistax film coated tablets
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Antistax film coated tablets
Primary Outcome Measure Information:
Title
Number and intensity of serious and non-serious Adverse Events
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Global tolerability assessment by the patient and investigator
Time Frame
after 42 days of treatment
Title
Vital sign parameters (blood pressure and pulse rate)
Time Frame
at screening and after 6 weeks
Title
Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)
Time Frame
Baseline and after 6 weeks
Title
Global assessment of efficacy by the patient and investigator
Time Frame
after 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.5_U02-0199.pdf
Description
Related Info
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Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)
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