Venous InsufficiencyPhase 2NCT02191163
Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency
A Phase 2 study testing Antistax® in people with Venous Insufficiency, run by Boehringer Ingelheim.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Antistax®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Aug 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Concomitant disease(s) exclusion criteria:
- 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)
Show all 33Show fewer
- 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
- Recognized hypersensitivity to the trial drug ingredients
- Current florid venous ulcus
- Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc.
- Previous treatment(s) exclusion criteria:
- Treatment with venous drugs within the last 4 weeks
- Changes in, or initiation with, treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days
- Concomitant treatment/non-drug therapy exclusion criteria:
- Other venous drugs apart from the trial medication
- Compression bandages
- Venous surgery of the leg used for the fluxmetry
- Extensive use (i.e. on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance
- Major surgery requiring full anesthesia
- Other exclusion criteria:
- Previously studied under this protocol
- Participation in another clinical trial within the previous 90 days or during the present study
- Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial
- Patients in a bad general health state according to the investigator's judgment
About this study
Official title: A 17 Week, Randomised, Double-blind, Placebo Controlled Cross-over Trial to Evaluate the Efficacy of Antistax® Film Coated Tablets (Extr. Vitis Vinifera Siccum), 360 mg/Day p.o. in Improving Microcirculation of the Skin in the Leg of Male and Female Patients Suffering From Chronic Venous Insufficiency
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
- Being tested
- Antistax®, Placebo
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antistax®Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Antistax® | Experimental | 1 x 360 mg for 42 days Receives: Drug: Antistax® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, after 6 weeks of treatment
Secondary outcomes (14)
Changes from baseline in the resting flux
measured in the frequency range 10-37 kHz
Measured: Baseline, after 3 weeks of treatment
Changes in the resting flux
measured in the frequency range <10 kHz
Measured: Baseline, after 3 and 6 weeks of treatment
Changes in the combined resting fluxes (<37 kHz)
Measured: Baseline, after 3 and 6 weeks of treatment
Changes in the transcutaneous oximetry (TcPO2)
measured on the inside lower leg of the more CVI-affected leg
Measured: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the calf circumference of the most affected leg
Measured: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the ankle circumference of the most affected leg
Measured: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
Measured: Baseline, after 3 and 6 weeks of treatment
Global efficacy assessment by patient on a 4-point verbal rating scale (VRS)
Measured: after 6 weeks of treatment
Global efficacy assessment by investigator on a 4-point VRS
Measured: after 6 weeks of treatment
Number of patients with adverse events
Measured: up to 16 weeks
Number of patients with clinically relevant changes in laboratory values
Measured: Baseline, up to 16 weeks
Number of patients with clinically significant changes in vital signs
Measured: Baseline, up to 16 weeks
Global tolerability assessment by investigator on a 4-point VRS
Measured: after 6 weeks of treatment
Global tolerability assessment by patient on a 4-point VRS
Measured: after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startApr 2002
- Primary completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191163
- Sponsor's protocol ID
- 1138.3
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
Publications
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.
PubMed 33141449
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 17 Week, Randomised, Double-blind, Placebo Controlled Cross-over Trial to Evaluate the Efficacy of Antistax® Film Coated Tablets (Extr. Vitis Vinifera Siccum), 360 mg/Day p.o. in Improving Microcirculation of the Skin in the Leg of Male and Female Patients Suffering From Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT02191163
- Acronym / sponsor ID
- 1138.3
- Conditions
- Venous Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Aug 2002 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antistax® | Experimental | Drug: Antistax®1 x 360 mg for 42 days |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (33 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antistax® | Drug | Antistax® |
| Placebo | Drug | Placebo |
Primary outcome
Changes from baseline in the resting flux
Time frame: 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
14 secondary outcomes
Changes from baseline in the resting flux
Time frame: Baseline, after 3 weeks of treatment
Changes in the resting flux
Time frame: Baseline, after 3 and 6 weeks of treatment
Changes in the combined resting fluxes (<37 kHz)
Time frame: Baseline, after 3 and 6 weeks of treatment
Changes in the transcutaneous oximetry (TcPO2)
Time frame: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the calf circumference of the most affected leg
Time frame: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the ankle circumference of the most affected leg
Time frame: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
Time frame: Baseline, after 3 and 6 weeks of treatment
Global efficacy assessment by patient on a 4-point verbal rating scale (VRS)
Time frame: after 6 weeks of treatment
Global efficacy assessment by investigator on a 4-point VRS
Time frame: after 6 weeks of treatment
Number of patients with adverse events
Time frame: up to 16 weeks
Number of patients with clinically relevant changes in laboratory values
Time frame: Baseline, up to 16 weeks
Number of patients with clinically significant changes in vital signs
Time frame: Baseline, up to 16 weeks
Global tolerability assessment by investigator on a 4-point VRS
Time frame: after 6 weeks of treatment
Global tolerability assessment by patient on a 4-point VRS
Time frame: after 6 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Derived from this study: PubMed 33141449Martinez-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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antistax® in people with Venous Insufficiency, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in the resting flux (time frame: Baseline, after 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02191163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.