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    Summary
    EudraCT Number:2005-006191-35
    Sponsor's Protocol Code Number:D9612L00088
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-05-16
    Trial 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 number2005-006191-35
    A.3Full title of the trial
    Tumorfreies Überleben nach Ablation von Barrett-Schleimhaut Plus Esomeprazol versus tumorfreies Überleben unter Esomeprazol ohne Ablation von Barrett-Schleimhaut bei Patienten, die von einem „Barrett-Karzinom“ geheilt wurden, kombiniert mit Randomisierung von Esomeprazol versus Placebo zur symptomatischen Refluxkontrolle nach erfolgreicher Ablation der Barrett-Mukosa

    English translation: Tumor-free survival after ablation of Barrett-mucosa plus esomeprazole versus tumor-free survival under esomeprazole without ablation of Barrett-mucosa in patients healed from a „Barrett-carcinoma“, combined with randomization to esomeprazole versus placebo for symptomatic reflux control after successful ablation of Barrett-mucosa
    A.3.2Name or abbreviated title of the trial where available
    APE-Studie
    A.4.1Sponsor's protocol code numberD9612L00088
    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 SponsorHSK, Dr. Horst Schmidt Kliniken GmbH
    B.1.3.4CountryGermany
    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 No
    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 nameEsomeprazol gastro-resistant tablets 40 mg
    D.3.2Product code Esomeprazol
    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.3.8INN - Proposed INNESOMEPRAZOLE
    D.3.9.1CAS number 119141887
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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
    Endoscopically treated Barrett-adenocarcinoma with complete remission
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10004137
    E.1.2Term Barrett's oesophagus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that thermal ablation of residual long segments of metaplastic, non-neoplastic Barrett-mucosa (> 2 cm) after successful endoscopic therapy with EMR under concomitant acid suppression with esomeprazole reduces the incidence of secondary neoplasias (local recurrence and metachronic neoplasia) during 5-year follow-up in comparison to acid suppression with esomeprazole alone without thermal ablation (study objective secondary prevention; primary study end point: secondary neoplasia during 5-year follow-up; secondary study end points: completion of 5-year follow-up or premature termination of the study).
    E.2.2Secondary objectives of the trial
    To demonstrate that patients after successful thermal ablation require continuation of acid suppressive therapy with proton pump inhibitors for symptomatic control of the underlying reflux disease (study objective: control of reflux symptoms; primary study end point: occurrence of reflux symptoms under double-blind medication of esomeprazole vs. placebo; secondary study end points: completion of 5-year follow-up or premature termination of the study).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Endoscopically (lateral extent) and histologically (basal extent) proven complete remission after endoscopic therapy of a mucosal Barrett-adenocarcinoma (endoscopic resection +/- thermal treatment of resection margins) (complete remission)
    - Initial length of Barrett-segment prior to therapy of Barrett-carcinoma >3 cm (tongues and circumferential part together) (initial LSBE)
    - Histologically proven presence of non-neoplastic Barrett-mucosa of at least 2 cm extent (longitudinal or radial extent (no high grade intraepithelial neoplasia or adenocarcinoma in at least 4 biopsies per 2 cm Barrett-segment) (present Barrett-segment >2 cm)
    - Adult patient and informed consent to repeated endoscopic examinations (diagnostic and therapeutic) as well as to continuous drug therapy with proton pump inhibitors (PPI, esomeprazole) (informed consent)
    E.4Principal exclusion criteria
    - Previous attempt of ablation of non-neoplastic Barrett-mucosa (irrespective of time and method; not valid with regard to previous administration of ablative methods for the treatment of neoplastic Barrett-mucosa; previous ablation)
    - Time interval to achieve complete remission of Barrett-carcinoma >12 months (from first to last endoscopic therapy; prolonged therapy phase)
    - Time interval between achievement of complete remission and enrollment to this trial of more than 24 months (delay between therapy and secondary prophylaxis)
    - Barrett-carcinoma that is the cause for checking participation in the present trial is a recurrence of a previously known and pre-treated carcinoma (Barrett-carcinoma-recurrence)
    - History of repeatedly poor or lacking healing of therapeutically induced ulcerations (chronic EMR-ulcer)
    - No detectable Barrett-mucosa after completion of primary therapy or when complete remission was achieved (no Barrett-mucosa)
    - Being unwilling or unable to take proton pump inhibitors (PPI, esomeprazole) regularly and for a long time (no PPI-compliance)
    - Co-morbidity of malignant diseases or life expectancy <1 year
    - Pregnancy and lactation period (women of childbearing potential must use reliable contraceptive measures during the trial: e.g., hormonal contraceptives, intrauterine device, condoms, abstinence)
    - Age below 18 years
    - Inability or doubts with regard to ability of the patient to understand nature, significance, implications and risks of the clinical trial and to take appropriate decisions
    - Missing signed declaration of consent after appropriate information
    - Known intolerance to esomeprazole, substituted benzimidazoles or one of the other ingredients of trial medication
    - Known fructose-intolerance, glucose-galactose-malabsorption or saccharase-isomaltase-deficiency
    - Increased bleeding risk during therapeutic endoscopic procedures (thrombocytopenia, plasmatic coagulation disorders, history of bleeding tendency, esophageal varices, liver cirrhosis Child-Pugh B/C), renal insufficiency requiring dialysis or other clinically relevant risks according to the investigator’s opinion
    - Participation in another clinical trial within one month prior to or during the present trial
    - Previous participation in this trial
    E.5 End points
    E.5.1Primary end point(s)
    (1) primary end point of main study objective secondary prevention: incidence of secondary neoplasias (Barrett-adenocarcinoma and high-grade neoplasia) during follow-up and time of occurrence (secondary end points: individual completion of 5-year follow-up without secondary neoplasia, premature termination of the study, death)

    (2) primary end point of the secondary study objective Barrett-ablation: feasibility, completeness and safety of Barrett-ablation with APC (secondary end points: failure of APC-ablation >90 % of Barrett-segment, recurrence of non-neoplastic Barrett-esophagus, individual completion of 5-year follow-up without secondary neoplasia, premature termination of the study, death)

    (3) primary end point of the secondary study objective reflux control: symptomatic or endoscopic recurrence of reflux disease after successful thermal ablation of residual long segments of metaplastic, non-neoplastic Barrett-mucosa (> 2 cm) after successful endoscopic therapy of an early mucosal Barrett-carcinoma with EMR (secondary end points: completion of 2-year follow-up without experiencing a symptomatic or endoscopic relapse (secondary study objective reflux control), completion of 5-year follow-up without secondary neoplasia (main study objective, secondary end point), secondary neoplasia during follow-up, Barrett-Neoplasia during follow-up, premature termination of the study, death)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Primary Objective: Open. Secondary Objective: Double-Blind
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    End of the trial is completion of the study by the last subject dfined as reaching one of the following end points: Lost to follow-up; reflux; neoplasia; end of follow-up phase after 5 years or death
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 state280
    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 termination of the study patients are treated according to the investigator'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 Decision2006-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-07-16
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