Venous Insufficiency
Conditions
Brief summary
Study to determine the efficacy and safety of Antistax® film coated tablets in improving microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)
Interventions
DRUGAntistax®
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * \>= 18 years of age * CVI I or CVI II (without expanded trophic disturbances) * Willing and able to give written informed consent in accordance to Good Clinical Practice and local legislation prior to participation in the study
Exclusion criteria
Concomitant disease(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in the resting flux | Baseline, after 6 weeks of treatment | measured in the frequency range 10-37 kHz on the skin of the inside lower leg using the Laser Doppler Fluxmetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the resting flux | Baseline, after 3 and 6 weeks of treatment | measured in the frequency range \<10 kHz |
| Changes in the combined resting fluxes (<37 kHz) | Baseline, after 3 and 6 weeks of treatment | — |
| Changes in the transcutaneous oximetry (TcPO2) | Baseline, after 3 and 6 weeks of treatment | measured on the inside lower leg of the more CVI-affected leg |
| Change from baseline in the calf circumference of the most affected leg | Baseline, after 3 and 6 weeks of treatment | — |
| Change from baseline in the ankle circumference of the most affected leg | Baseline, after 3 and 6 weeks of treatment | — |
| Change from baseline in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS) | Baseline, after 3 and 6 weeks of treatment | — |
| Changes from baseline in the resting flux | Baseline, after 3 weeks of treatment | measured in the frequency range 10-37 kHz |
| Global efficacy assessment by investigator on a 4-point VRS | after 6 weeks of treatment | — |
| Number of patients with adverse events | up to 16 weeks | — |
| Number of patients with clinically relevant changes in laboratory values | Baseline, up to 16 weeks | — |
| Number of patients with clinically significant changes in vital signs | Baseline, up to 16 weeks | — |
| Global tolerability assessment by investigator on a 4-point VRS | after 6 weeks of treatment | — |
| Global tolerability assessment by patient on a 4-point VRS | after 6 weeks of treatment | — |
| Global efficacy assessment by patient on a 4-point verbal rating scale (VRS) | after 6 weeks of treatment | — |
Outcome results
None listed