Venous Insufficiency
Conditions
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
Interventions
DRUGAntistax®, low dose
DRUGAntistax®, high dose
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline of limb volume | Baseline, day 84 | determined by water displacement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Assessment of global efficacy by investigator on a 4-point verbal rating scale | days 42, 84 and 98 | — |
| Assessment of global tolerability by patient on a 4-point verbal rating scale | days 42, 84 and 98 | — |
| Measurement of ankle circumference | Baseline, days 42, 84 and 98 | in centimeters |
| Changes of limb volume | Baseline, days 42 and 98 | determined by water displacement |
| Measurement of calf circumference | Baseline, days 42, 84 and 98 | in centimeters |
| Number of patients with adverse events | up to 14 weeks | — |
| Assessment of global tolerability by investigator on a 4-point verbal rating scale | days 42, 84 and 98 | — |
Outcome results
None listed