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    Summary
    EudraCT Number:2006-004774-27
    Sponsor's Protocol Code Number:ART108053
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-19
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-004774-27
    A.3Full title of the trial
    Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebO (CALISTO).

    An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications
    A.4.1Sponsor's protocol code numberART108053
    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 SponsorGlaxoSmithKline Research & Development Ltd.
    B.1.3.4CountryUnited Kingdom
    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 ARIXTRA
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXO Group LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameARIXTRA
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFondaparinux Sodium
    D.3.9.1CAS number 114870-03-0
    D.3.9.2Current sponsor codeGSK576428
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 placeboInjection*
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Superficial Thrombophlebitis (also known as superficial vein thrombosis)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10042557
    E.1.2Term Superficial thrombophlebitis of leg
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate the efficacy of fondaparinux 2.5
    mg once daily versus placebo with respect to the occurrence of the primary efficacy
    endpoint (symptomatic VTE events and/or death) from any cause up to Day 45 (end of treatment period) in patients with isolated ST of the lower limbs.
    The principal safety endpoint of the study is to evaluate fondaparinux 2.5 mg once daily versus placebo with respect to the occurrence of major bleeding and/or death up to Day 49 (end of treatment period plus four days) in patients with isolated ST of the lower limbs.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to demonstrate the efficacy of fondaparinux
    2.5 mg once daily versus placebo with respect to the occurrence of symptomatic VTE
    events and/or death from any cause up to Day 75 (end of follow-up) in patients with
    isolated ST of the lower limbs
    The principal safety endpoint will also be evaluated up to Day 75.
    Other safety objectives of the study are to evaluate the overall safety of fondaparinux 2.5 mg once daily versus placebo with respect to symptomatic arterial thromboembolic events and other adverse events (AE).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Fondaparinux Sodium Investigator’s Brochure.
    Subjects eligible for enrolment in the study must meet all the following criteria:
    • Hospitalised or non-hospitalised male or female patients 18 years of age or greater ,
    • With acute symptomatic isolated ST of the lower limbs at least 5 cm long
    documented by standard CUS,
    • Able and willing to provide written informed consent.
    Acute ST is ST in which the delay between symptom onset and randomisation is less than three weeks.
    Isolated ST is ST without concomitant asymptomatic or symptomatic DVT and/or
    symptomatic PE. On CUS, ST will be defined as a subcutaneous non-compressible hypoechoic area in the course of an identified superficial vein (looking circular in cross sectional view, and quite rectangular in longitudinal view) of more than 5 cm in length [The STENOX Study Group, 2003] and more than 3 mm in maximum antero-posterior diameter under compression. The thrombosed vein will be named according to the anatomical nomenclature [Caggiati, 2006] and the UIP (Union Internationale de Phlébologie) consensus [Cavezzi, 2006; Coleridge, 2006].
    In France, a subject will be eligible for inclusion in this study if either affiliated to or a
    beneficiary of a social security category. This is an additional inclusion criterion only
    applying to subjects enrolled in France.
    E.4Principal exclusion criteria
    Exclusion criteria related to disease characteristics at presentation:
    • ST following sclerotherapy or resulting as a complication of an intravenous
    line,
    • Palpable hard cord without any inflammation and, on CUS, with an anteroposterior
    diameter < 5 mm and uniformly hyperechoic (high probability of old ST),
    • Delay between symptom onset and randomisation greater than 21 days,
    • Delay between diagnosis by CUS and randomisation greater than 48 hours
    (exceptionally, if the delay between CUS and randomisation exceeds this
    time period, the patient may be randomised if eligibility is confirmed by
    repeat CUS),
    • Treatment with antithrombotic or anticoagulant therapy, including low-dose
    anticoagulation, for more than 48 hours prior to randomisation,
    • Treatment with oral NSAIDs for more than 72 hours prior to randomisation,
    • Treatment with aspirin at doses greater than 325 mg per day for more than
    72 hours prior to randomisation,
    • ST within 3 cm from the sapheno-femoral junction,
    • Symptomatic or asymptomatic DVT on qualifying CUS,
    • Documented presence of symptomatic PE,
    • Requirement for ligation of the sapheno-femoral junction, thrombectomy or planned intervention for stripping of varicose veins during the study period,
    • History of documented ST occurring within the last 90 days,
    • History of documented DVT or PE within the last six months,
    • ST in patients with active cancer (i.e. treated for cancer within the last six
    months).
    Exclusion criteria related to concomitant medication:
    • Anticoagulant therapy required or likely to be required during the study
    period (e.g. planned surgery justifying pharmacological thromboprophylaxis),
    • Treatment with aspirin at a dose greater than 325 mg per day or oral
    NSAIDs (at any dose) required or likely to be required during the study period.
    Exclusion criteria related to study treatments:
    • Known hypersensitivity to fondaparinux or its excipient,
    • Women of childbearing potential not using a reliable contraceptive method
    throughout the study period (a list of reliable contraceptive methods is provided in the accompanying SPM),
    • Pregnant or breast-feeding women during the study period.
    Exclusion criteria based on risk of bleeding:
    • Active, clinically significant bleeding,
    • Clinically significant bleeding within the past month,
    • Patient judged by the investigator to be at high risk of bleeding,
    • Major surgery within the previous three months,
    • Ophthalmic, spinal, and/or brain surgery within the previous twelve months,
    • Haemorrhagic stroke within the previous twelve months,
    • Severe head injury within the previous three months,
    • Documented congenital or acquired bleeding tendency/disorder(s),
    • Previous or active peptic ulcer disease,
    • Uncontrolled arterial hypertension (systolic blood pressure over 180 mm Hg
    or diastolic blood pressure over 110 mm Hg),
    • Treatment with two or more antiplatelet agents (e.g. clopidogrel and aspirin)
    at any dose,
    • Bacterial endocarditis,
    • Severe hepatic impairment,
    • Platelet count below 100×109/L,
    • Prothrombin time ratio below 50%,
    • Calculated creatinine clearance < 30 mL/min,
    • Body weight < 50 kg.
    Other exclusion criteria related to trial methodology:
    • Any condition that could prevent the patient from providing written
    informed consent or from adhering to study treatment,
    • Life expectancy under three months,
    • Participation in any study using an investigational drug during the previous three months,
    • Patient in whom follow-up to Day 75 is unlikely to be feasible (e.g. patient
    moving to another country).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is VTE and/or death from any cause up to Day 45 (end of study treatment period). VTE is defined in this study as a composite of symptomatic PE, symptomatic DVT, symptomatic recurrence of ST or symptomatic extension of ST.
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA124
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days14
    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 No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1156
    F.4.2.2In the whole clinical trial 2316
    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 Decision2007-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-31
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