Antistax® in Patients With Chronic Venous Insufficiency
The Ability of Antistax® to Improve Chronic Venous Insufficiency (CVI) I and II in Male and Female Patients: a Dose Response Study
1 other identifier
interventional
260
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 1998
CompletedFirst Submitted
Initial submission to the registry
July 15, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedJuly 16, 2014
July 1, 2014
5 months
July 15, 2014
July 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Changes from baseline of limb volume
determined by water displacement
Baseline, day 84
Secondary Outcomes (9)
Changes of limb volume
Baseline, days 42 and 98
Measurement of calf circumference
Baseline, days 42, 84 and 98
Measurement of ankle circumference
Baseline, days 42, 84 and 98
Assessment of subjective symptoms on a visual analogue scale (VAS)
Baseline, days 42, 84 and 98
Assessment of global efficacy by patient on a 4-point verbal rating scale
days 42, 84 and 98
- +4 more secondary outcomes
Study Arms (3)
Antistax®, low dose
EXPERIMENTALAntistax®, high dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33141449DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2014
First Posted
July 16, 2014
Study Start
April 1, 1998
Primary Completion
September 1, 1998
Last Updated
July 16, 2014
Record last verified: 2014-07