Venous InsufficiencyPhase 2NCT02191280
Antistax® in Patients With Chronic Venous Insufficiency
A Phase 2 study testing Antistax®, low dose and Antistax®, high dose in people with Venous Insufficiency, run by Boehringer Ingelheim.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Antistax®, low dose and Antistax®, high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Sep 1998
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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)
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- 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
- 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
- Treatment with laxatives which affect fluid or electrolyte balance within the last 8 days
- Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days
- Changes in post-menopausal Hormone replacement within the last 2 months
- Concomitant treatment/non-drug therapy exclusion criteria:
- Other venous drugs apart from the trial medication
- Compression therapy
- Venous surgery at the leg(s)
- Extensive use (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 who have visited a sauna or had other thermal applications in the previous day before any visit
- Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
- 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: The Ability of Antistax® to Improve Chronic Venous Insufficiency (CVI) I and II in Male and Female Patients: a Dose Response Study
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
- Conditions
- Venous Insufficiency
- Being tested
- Antistax®, low dose, Antistax®, high dose, 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®, low doseDrug
Antistax®, high doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Antistax®, low dose | Experimental | Not described Receives: Drug: Antistax®, low dose |
| Antistax®, high dose | Experimental | Not described Receives: Drug: Antistax®, high dose |
| 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 of limb volume
determined by water displacement
Measured: Baseline, day 84
Secondary outcomes (9)
Changes of limb volume
determined by water displacement
Measured: Baseline, days 42 and 98
Measurement of calf circumference
in centimeters
Measured: Baseline, days 42, 84 and 98
Measurement of ankle circumference
in centimeters
Measured: Baseline, days 42, 84 and 98
Assessment of subjective symptoms on a visual analogue scale (VAS)
Measured: Baseline, days 42, 84 and 98
Assessment of global efficacy by patient on a 4-point verbal rating scale
Measured: days 42, 84 and 98
Assessment of global efficacy by investigator on a 4-point verbal rating scale
Measured: days 42, 84 and 98
Assessment of global tolerability by patient on a 4-point verbal rating scale
Measured: days 42, 84 and 98
Assessment of global tolerability by investigator on a 4-point verbal rating scale
Measured: days 42, 84 and 98
Number of patients with adverse events
Measured: up to 14 weeks
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 1998
- Primary completionSep 1998
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 260 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
- NCT02191280
- Sponsor's protocol ID
- 1138.2
- 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
- The Ability of Antistax® to Improve Chronic Venous Insufficiency (CVI) I and II in Male and Female Patients: a Dose Response Study
- ClinicalTrials.gov ID
- NCT02191280
- Acronym / sponsor ID
- 1138.2
- Conditions
- Venous Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Sep 1998 (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 tolerability of two dose levels of Antistax relative to placebo in patients suffering from CVI grade I or incipient grade II
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antistax®, low dose | Experimental | Drug: Antistax®, low dose |
| Antistax®, high dose | Experimental | Drug: Antistax®, high dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (36 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®, low dose | Drug | Antistax®, low dose |
| Antistax®, high dose | Drug | Antistax®, high dose |
| Placebo | Drug | Placebo |
Primary outcome
Changes from baseline of limb volume
Time frame: Baseline, day 84
determined by water displacement
9 secondary outcomes
Changes of limb volume
Time frame: Baseline, days 42 and 98
Measurement of calf circumference
Time frame: Baseline, days 42, 84 and 98
Measurement of ankle circumference
Time frame: Baseline, days 42, 84 and 98
Assessment of subjective symptoms on a visual analogue scale (VAS)
Time frame: Baseline, days 42, 84 and 98
Assessment of global efficacy by patient on a 4-point verbal rating scale
Time frame: days 42, 84 and 98
Assessment of global efficacy by investigator on a 4-point verbal rating scale
Time frame: days 42, 84 and 98
Assessment of global tolerability by patient on a 4-point verbal rating scale
Time frame: days 42, 84 and 98
Assessment of global tolerability by investigator on a 4-point verbal rating scale
Time frame: days 42, 84 and 98
Number of patients with adverse events
Time frame: up to 14 weeks
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.
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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®, low dose and Antistax®, high dose 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 36 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 of limb volume (time frame: Baseline, day 84). 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 NCT02191280, 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.