Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency

NCT02191163 | Completed Phase 2

• 1 other identifier: 1138.3
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in the resting flux

  measured in the frequency range 10-37 kHz on the skin of the inside lower leg using the Laser Doppler Fluxmetry

  Baseline, after 6 weeks of treatment

Secondary Outcomes (14)

• Changes from baseline in the resting flux

  Baseline, after 3 weeks of treatment

• Changes in the resting flux

  Baseline, after 3 and 6 weeks of treatment

• 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

• Change from baseline in the calf circumference of the most affected leg

  Baseline, after 3 and 6 weeks of treatment

Study Arms (2)

Antistax®

EXPERIMENTAL

1 x 360 mg for 42 days

Drug: Antistax®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Antistax® DRUG

Antistax®

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
• Severe climacteric complaints or changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months
• Immobility
• Avalvulie
• Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
• State after pulmonary embolism

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: 33141449 DERIVED

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Antistax

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: April 1, 2002
• Primary Completion: August 1, 2002
• Last Updated: July 16, 2014

Record last verified: 2014-07