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    Summary
    EudraCT Number:2005-002441-39
    Sponsor's Protocol Code Number:D961DC00001
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-07-05
    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 ConcernedNorway - NOMA
    A.2EudraCT number2005-002441-39
    A.3Full title of the trial
    A randomised, double-blind, parallel-group, placebo controlled study of
    esomeprazole i.v. (bolus infusion of 80 mg followed by a continuous infusion
    of 8 mg per hour) administered for 72 hours to assess prevention of
    rebleeding in subjects that have undergone successful primary endoscopic
    haemostasis of a bleeding peptic ulcer – the PUB study
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberD961DC00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    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 nameNexium 40 mg powder for solution for injection/infusion
    D.3.2Product code Esomeprazole powder for solution for injection/inf
    D.3.4Pharmaceutical form Powder for infusion*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEsomeprazole sodium
    D.3.9.1CAS number 161796-78-7
    D.3.9.2Current sponsor codeEsomeprazole sodium
    D.3.9.3Other descriptive nameH 199/18 sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 2
    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 Information not present in EudraCT
    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 nameEsomeprazole capsules 40 mg (unmarked capsules for clinical trial use)
    D.3.2Product code Esomeprazole capsules 40 mg
    D.3.4Pharmaceutical form Capsule, hard
    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 magnesium trihydrate
    D.3.9.1CAS number 217087-09-7
    D.3.9.2Current sponsor codeEsomeprazole magnesium trihydrate
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    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 placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gatrointestinal haemorrhages NEC. (Bleeding gastric or duodenal ulcer will be investigated).

    MedDRA classification code Level: HLGT = High Level Group Term. See below.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level HLGT
    E.1.2Classification code 10017959
    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 is to compare, in subjects with PUB after successful endoscopic haemostasis, the efficacy of 72 hours continuous i.v. infusion of either esomeprazole or placebo by assessment of the rate of clinically significant rebleeding during the i.v. treatment period.
    E.2.2Secondary objectives of the trial
    To compare, in subjects with PUB after successful endoscopic haemostasis, 72 hours continuous i.v. infusion of either esomeprazole or placebo with regard to the following, where the time period begins at start of i.v. treatment:
    1. The rate of clinically significant rebleeding within 7 days and 30 days.
    2. Proportion of mortalities within 72 hours and 30 days.
    3. Rate of “bleed-related” mortalities within 30 days, based on the assessments by the Endpoint Committee (EpC).
    4. Proportion of subjects who, within 72 hours and 30 days, had surgery (except endoscopic treatment) due to rebleeding.
    5. Proportion of subjects who within 72 hours and 30 days, had endoscopic re-treatment due to rebleeding.
    6. Number of blood units transfused within 72 hours and 30 days.
    7. Number of days hospitalised due to rebleeding within 30 days.
    8. Safety and tolerability.
    In addition, the safety and tolerability of open oral treatment of esomeprazole 40 mg for 27 days will be assessed.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    For inclusion in the study, subjects must fulfil all of the following criteria:
    1. Provision of informed consent.
    2. Female or male aged 18 years and over.
    3. Upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or with such sign within the last 24 hours as judged by the investigator.
    4. One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding is required.

    Forrest classification of PUB (Forrest et al 1974):
    Ia = arterial bleeding
    Ib = oozing bleeding
    IIa = non-bleeding visible vessel
    IIb = adherent clot

    In case of Forrest IIb (adherent clot), all efforts should be made to remove the clot. If the clot cannot be removed, it is to be handled as follows:
    - If the clot can be removed with 5 min of high-pressure water irrigation (Laine et al 1996) or by cold snare, the ulcer should be reclassified and only Forrest Ia, Ib and IIa should be included.
    - If the clot cannot be removed despite these measures, the subject should be included as Forrest IIb.

    5. Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment with:
    - Injection therapy (epinephrine, dilution 1:10000)
    and/or one of the following:
    - Coagulation with heater probe
    - Electrocautery
    - Haemoclips.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
    2. The ASA classification (Appendix C) of physical status > 3 as judged by the investigator.
    3. Severe hepatic disease defined as Child-Pugh B or C (Appendix D).
    4. Severe renal disease, defined as subject requiring dialysis or subject in imminent need of dialysis as judged by the investigator.
    5. Major cardiovascular event at enrolment or within 3 months prior to study start, such as stroke, myocardial infarction, or hospitalisation for treatment of unstable angina pectoris as judged by the investigator.
    6. Haemorrhagic disorder, platelets <100x10e9/L, INR>1.5, APTT>1.5x upper limit of normal (ULN), or treatment with low-molecular weight heparin.
    7. Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.
    8. Sign of multiple bleeding peptic ulcers or concomitant other gastrointestinal bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy’s lesion, colon, small bowel, or ulcer distal to the stoma in Billroth-resected subjects.
    9. Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) and clopidogrel.
    10. Known or suspected hypersensitivity to any component of any PPI (esomeprazole, omeprazole, lansoprazole, rabeprazole, or pantoprazole).
    11. Planned treatment with medication that could interact with esomeprazole; ie, phenytoin, clarithromycin, itraconazole, ketoconazole, warfarin (including other vitamin K antagonists), cisapride, atazanavir and ritonavir.
    12. Chemotherapy or radiation therapies within 2 weeks prior to study start or planned during the course of the study.
    13. Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
    14. Known or suspected alcohol, drug or medication abuse, or any condition associated with poor compliance as judged by the investigator.
    15. Participation in any study of investigational drugs within the preceding 30 days prior to enrolment.
    16. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site).
    17. Previous enrolment in the present study.
    18. Intravenous administrationof a PPI (esomeprazole, omeprazole, lansoprazole, rabeprazole or pantoprazole) exceeding a total dose of 40 mg within 24 hours prior to enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    There is no primary endpoint in this study.

    Primary outcome variable: Clinically significant rebleeding within 72h of continues infusion of esomeprazole or placebo.
    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 Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 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 study is defined as database lock, which is the time point after which no subject will be exposed to study related activities.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Information not present in EudraCT
    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 2005-07-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 760
    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)
    NA
    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 Decision2005-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-01
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