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    Summary
    EudraCT Number:2008-003932-40
    Sponsor's Protocol Code Number:1138.11
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2008-003932-40
    A.3Full title of the trial
    A 12-week, double-blind, randomised, placebo-controlled, multicentre trial to evaluate efficacy and tolerability of Antistax® film-coated tablets, 720mg/day orally, in male and female patients suffering from chronic venous insufficiency.
    A.4.1Sponsor's protocol code number1138.11
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoerhinger Ingelheim Pharma GmbH & Co.KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Antistax®
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharma GmbH & Co.KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAntistax
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic venous insufficiency
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066682
    E.1.2Term Chronic venous insufficiency
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to assess the efficacy and tolerablity of Antistax® film-coated tablets in patients with chronic venous insufficiency (CVI, CEAP Classification: Clinical Class 3 and 4a)
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female
    2. 18 years of age or older
    3. CVI, Clinical Class 3 and Class 4a according to the CEAP classification
    4. Presence of stable oedema determined by a pretibial pit after a 30 seconds pressure with the thumb documented by a photo
    5. Stable and reproducible status of swelling documented by a difference of less than 150 g between screening and baseline as determined by water displacement method
    6. Presence of moderate to severe varicosis (dilated, tortuous veins in the subcutaneous tissue with a diameter of more than 3 mm)
    7. Intensity of leg pain equal to or more than 3 cm on the Visual Analogue Scale at baseline and presence of moderate to severe oedema
    8. Willing and able to give written informed consent prior to participation in the trial
    9. Patients expected to be compliant (compliance with run-in medication >80%, as checked by drug count)
    E.4Principal exclusion criteria
    A. Concomitant diseases
    1. Decompensated cardiac insufficiency according to the New York Heart Association (NYHA) classification III and IV for cardiac patients, see Appendices
    2. Oedema not due to venous disease of the legs (e.g., latent cardiac insufficiency,
    renal insufficiency, lymphoedema, etc)
    3. Severe skin changes, e.g. lipodermatosclerosis
    4. Current florid venous ulcer
    5. Peripheral arterial disease (ankle/arm pressure index < 0.9)
    6. Untreated or insufficiently controlled hypertension
    7. Current acute phlebitis or thrombosis within the last 3 months. Patients with a post-thrombotic syndrome, who do not currently receive an anticoagulation treatment, can be included in the trial.
    8. Renal insufficiency
    9. Liver disease; hepatic insufficiency
    10. Hyper- or hypocalcaemia
    11. Malignancies
    12. Anamnestic indications of diabetic microangiopathy or polyneuropathy
    13. Drug and/or alcohol abuse
    14. Severe climacteric complaints: changes in, or initiation of post-menopausal
    hormone replacement therapy within the last 3 months
    15. Immobility
    16. Avalvulia
    17. Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
    18. State after pulmonary embolism
    19. Recognised hypersensitivity to the trial drug ingredients
    20. Clinical indication for a specific phlebologic treatment, e.g. compression treatment, phlebectomy, etc.

    B. Previous treatments
    1. Compression therapy and/or wearing of support stockings less than 2 weeks prior to the visit at baseline (Visit 2).
    2. Venous surgery or sclerotherapy within the last 3 months at the leg used for volumetry.
    3. Treatment with drugs affecting the veins less than 4 weeks prior to Visit 1.
    4. Changes in or unstable response to treatment with theophylline, cardiac glycosides, ACE inhibitors, calcium antagonists, or laxatives within the last 2 weeks prior to Visit 1.

    C. Concomitant treatments
    During the whole period of the clinical trial, the following forms of therapy are not allowed since they may interfere with the efficacy and safety evaluation.
    1. Compression therapy
    2. Diuretics
    3. Nitrates
    4. Ergot alkaloids
    5. All preparations which are used as compounds for venous therapy in CVI (e.g. vasoprotectives for antivaricose therapy, preparations with heparin, sclerosing agents, flavonoid-containing preparations, other phytopharmaceuticals).
    6. Other drugs active on blood vessels and circulation
    7. Extensive use of laxatives
    8. Anticipated changes in the intake of hormones, i.e. contraceptives
    9. Scheduled major surgery requiring full anaesthesia

    D. Other exclusion criteria
    1. Previously studied under the present protocol
    2. Participation in another clinical trial within less than 90 days prior to Visit 1
    3. Participation in another clinical trial during the present trial
    4. Patient is investigator, co-investigator, trial nurse in this trial or is a relative of the investigator, co-investigator, or trial nurse in this trial
    5. Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only; reliable contraceptive methods are hormonal contraceptives, intra-uterine devices, sexual abstinence or sterilization)
    6. 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
    7. Patients in a bad general health state according to the investigator’s judgement
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in limb volume determination at day 84 (water displacement method)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    After the end of the patient`s study participation, the subject will be treated according to the investigator`s discretion
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-01-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of the trial, the patients will be treated according to physician`s discretion.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-17
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