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    Summary
    EudraCT Number:2008-001069-26
    Sponsor's Protocol Code Number:06/45/02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-001069-26
    A.3Full title of the trial
    Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins
    A.3.2Name or abbreviated title of the trial where available
    foam versus Surgery versus laser
    A.4.1Sponsor's protocol code number06/45/02
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number51995477
    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 SponsorUniversity of Aberdeen
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Fibro-vein
    D.2.1.1.2Name of the Marketing Authorisation holderCP Pharacetuticals
    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 nameFibro-vein
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Varicose Veins
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10047013
    E.1.2Term Varicose veins of lower extremities
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the clinical and cost-effectiveness of conventional surgery with two minimally invasive treatment modalities (a) foam sclerotherapy alone of main long or short saphenous trunk and non-trunk varicosities and (b) Endovenous laser ablation (EVLA) of main trunk including foam sclerotherapy of non-trunk varicosities, if required, performed under local anaesthetic in respect of quality of life for each intervention at 6 months (and ultimately through to 5 years) and cost-effectiveness as cost per quality adjusted life year (QALY) gained
    E.2.2Secondary objectives of the trial
    To compare the two novel interventions against conventional surgery in respect of:
    (i) Clinical success as determined by residual varicose veins, complication rates and return to normal activities.
    (ii) Technical success (duplex scan verified partial or complete ablation of, or the presence of reflux in, the main long or short saphenous trunk veins) at 6 months (and ultimately through to 5 years). In addition, any development of deep venous incompetence and neovascularisation up to 5 years.
    (iii) Cost to the health service and patients of each intervention and any subsequent care.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study 1 - Exeter Duplex sub-study (version 1, March 2009)
    This is a non-interventional sub-study (ie it does not involve any change to the IMP delivered as part of the CLASS trial). The sub-study will be carried out in one site only. The objectives are (i) to link patients' experiences of varicose vein symtoms with their varicose vein geograph and (ii) to establish, in patients treated with foam sclerotherapy, whether there is any relationship between the patients' view of the outcome of treatment and the duplex ultrasound haemodynamic evidence gathered post-procedure. No additional data is collected as part of this sub-study. However patients are required to give additional consent for their data to be used for this sub-study. The CLASS trial protocol does not change in light of this sub-study. A protocol for the sub-study has been developed and is enclosed.

    Sub-study 2 - VVaT sub-study (version 1, March 2009)
    This is a non-interventional sub-study (ie it does not involve any change to the IMP delivered as part of the CLASS trial). The sub-study will be carried out in one site only. The aim of the sub-study is to evaluate the quality of the leaflet (Varicose Veins and Treatment) as an information tool from a patient perspective. We propose to interview four patients who have agreed to take part in the CLASS study to find out their views on the leaflet in terms of how readable they found it. Patients will be given information about this interview based sub-study, and if they consent to take part, they will be asked to sign a consent form for this sub-study. The CLASS trial protocol does not change in light of this sub-study. A protocol for the sub-study has been developed and is enclosed.

    Sub-study 3 - A qualitative study to explore patient preferences about recruitment into the CLASS trial (version 1, March 2010)
    This is a non-interventional sub-study (ie it does not involve any change ot the IMP delivered as part of the CLASS trial). The sub-study will be carried out in one site only (Exeter). The aim is to integrate qualitative research methods into the recruitment processes to (i) understand information provision in consultations and (ii) explore participants’ views of the process to establish whether it is possible to improve these and increase trial recruitment. Patients potentially eligible for the CLASS trial will also be invited to participate in this sub-study. Consultations between consenting patients and consultant surgeons will be audio-recorded. Patients will be interviewed following consultations to understand their interpretation of the information provision and to explore their understanding of randomisation. Patients will be given information about this sub-study, and if they consent to take part, they will be asked to sign a consent form for one or both of the phases (audtio-recording/interview). The CLASS trial protocol does not change in light of this sub-study. A protocol for the sub-study has been developed and is enclosed, together with supporting documentation.
    E.3Principal inclusion criteria
    Adult patients (aged over 18 years old) who are referred to the surgical out-patient department for treatment of primary varicose veins with symptomatic (CEAP grade 2 or above) primary long or short saphenous main stem incompetence (reflux >1 second on duplex scanning) are eligible for inclusion.
    E.4Principal exclusion criteria
    Current deep vein thrombosis, acute superficial vein thrombosis, allergy to sclerosant, pregnancy or breast feeding, history of hypercoagulability, arterial disease (ankle brachial pressure index <0.8), inability to mobilise post-procedure, needle phobia, long or short saphenous vein less than 3mm in diameter or greater than 15mm and tortuous veins that are considered to be unsuitable for EVLA due to difficulties in passing the guide wire, inability to provide informed consent, inability to complete study questionnaires.

    Other exclusion criteria include those specifically mentioned on the fibro-vein (sodium tetradecyl sulphate) prescribing information leaflet which are: varicosities caused by pelvic or abdominal tumours, cardiac failure, pulmonary oedema, local or systemic infection.

    All varicose vein treatment should be used with care in patients taking oral contraceptives or hormonal replacement therapy. The treating surgeon will either ask the patient to discontinue the oral contraceptive or hormonal replacement therapy prior to treatment or will prescribe heparin prophylaxis therapy.

    Patients who are not fit for a general anaesthetic due to significant systemic disease, morbid obesity or other causes will be excluded from the trial.
    E.5 End points
    E.5.1Primary end point(s)
    We will assess outcomes up to 6 months, but with possible long-term follow-up to 5 years through a separate funding application.
    1. Primary patient outcome: Disease specific (Aberdeen Varicose Vein Questionnaire) and generic quality of life (EQ-5D, SF-36) at 6 months
    2. Primary economic outcome: Incremental cost per quality adjusted life years (QALY) at 6 months
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    (i) conventional surgery; (ii) endovenous laser ablation with foam sclerotherapy if required
    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 concerned11
    E.8.5The trial involves multiple Member States No
    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 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
    The end of clinical follow-up is the 6 month visit (last visit) of last subject recruited. The end of study is defined as the end of funding.
    The data monitioring committee will decide on any stop criteria other than completion of the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 2008-03-14. 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 state1015
    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)
    Treatment/care after the subject has ended his/her participation in the trial will not differ from the expected normal treatment of varicose veins.
    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 Decision2008-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-31
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