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    Summary
    EudraCT Number:2006-005073-22
    Sponsor's Protocol Code Number:D961FC00003
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-09
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2006-005073-22
    A.3Full title of the trial
    A randomized, double-blind, parallel-group study to assess the effect of esomeprazole 20 and 40 mg od versus placebo on the occurrence of peptic ulcers during 26 weeks in patients on continous low-dose aspirin.
    A.4.1Sponsor's protocol code numberD961FC00003
    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 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 nameEsomeprazole capsules 20 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.3.9.1CAS number 217087097
    D.3.9.3Other descriptive nameESOMEPRAZOLE MAGNESIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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 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 nameEsomeprazole 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.3.9.1CAS number 217087097
    D.3.9.3Other descriptive nameESOMEPRAZOLE MAGNESIUM
    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 placeboCapsule, hard
    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
    Target subject population are male and female subjects requiring low-dose acetylsalicylic acid (75-325 mg daily) who are Helicobacter pylori negative and who are at increased risk of developing gastroduodenal ulcers.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10017886
    E.1.2Term Gastroduodenal ulcer
    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 compare the effect of esomeprazole 20 and 40 mg once daily (od) versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid (ASA).
    E.2.2Secondary objectives of the trial
    Compare the effect of esomeprazole 20 and 40 mg od versus placebo on

    1+2. the occurrence of duodenal and gastric ulcers during 26 weeks in subjects on continuous low-dose ASA.
    3. subject- reported dyspeptic symptoms at the 26-week visit or the last visit, unless the last visit is the baseline visit, assessed by Reflux Disease Questionnaire (RDQ) in subjects on continuous low-dose ASA.
    4. subject- reported gastroesophageal reflux disease (GERD) symptoms (heartburn and regurgitation) at the 26-week visit or the last visit, unless the last visit is the baseline visit, assessed by RDQ in subjects on continuous low-dose ASA.

    5. Study the number of gastric and/or duodenal erosions during 26 weeks in subjects on continuous low-dose ASA, by treatment.
    6. Assess safety and tolerability of treatment with esomeprazole 20 and 40 mg od during 26 weeks in subjects on continuous low-dose ASA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent.
    2. Physician prescribed or recommended daily intake of low-dose aspirin (75-325 mg daily) that is expected to continue for the duration of the study (daily intake is defined as at least ≥5 days per week).
    3. The subject must fulfill at least one of the following (a-e):
    a) Aged ≥65 years.
    b) Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).
    c) Aged ≥60 years and naïve to low-dose aspirin (ie, treatment started within 1 month prior to randomization).
    d) Aged ≥60 years with stable coronary artery disease.
    e) Aged ≥60 years with complains of upper GI symptoms that, as judged by the investigator, requires an EGD and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.
    4. H. pylori negative. (H. pylori test to be performed according to local routines. Eradication treatment completed at least 4 weeks prior to randomization is allowed.).
    5. Able to read and write.
    E.4Principal exclusion criteria
    1. Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline EGD or within the last year as known by the investigator, or severe esophagitis within the last year as known by the subject (for definition, see Section 4.6.1.1).
    2. Peptic ulcer(s) at baseline EGD.
    3. History of peptic ulcer complications such as clinically significant bleeding and/or perforation.
    4. Any previous surgery of the stomach and/or the duodenum (except for laparoscopic fundoplication).
    5. Any of the following vascular diseases:
    - Unstable hypertension
    - History of Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention
    (PCI), Coronary Artery Bypass Graft (CABG) within the last 3 months
    - Clinically relevant valvular disease
    - Serious cardiac failure: New York Heart Association Functional Classification
    II–IV (NYHA II-IV), Ejection Fraction (EF) <40 %
    - Cerebrovascular accident within the last 3 months.
    6. Any current or historical evidence of the following diseases/conditions:
    - Malabsorption
    - Known esophageal stricture
    - Known Barrett’s esophagus with documented dysplastic changes of any grade
    - Zollinger-Ellison syndrome
    - Signs and symptoms of gastric outlet obstruction (eg, abdominal distension or
    multiple episodes of vomiting)
    - Pancreatitis
    - Unstable diabetes mellitus (as judged by the investigator). Stable diabetes
    controlled by diet, oral agents or insulin is acceptable
    - Atrophic gastritis
    - Short bowel syndrome.
    7. Evidence of any malignant disease within the last 5 years, except minor superficial skin disease.
    8. Continuous treatment with a NSAID including a cyclooxygenase-2 (COX-2)- selective NSAID during the last 2 months prior to randomization. During this period occasional use up to 1 day/per week is allowed.
    9. Ongoing anticoagulant therapy, such as warfarin or other vitamin K antagonists. Antiplatelets such as clopidogrel are allowed.
    10. Need for concomitant therapy with medication that could interact with esomeprazole, ie, phenytoin, ketoconazole, itraconazole, voriconazole, cisapride, atanzanavir, ritonavir.
    11. Known or suspected intolerance or hypersensitivity to esomeprazole or other PPIs or aspirin.
    12. Any use of a PPI or prostaglandin analogue within 14 days prior to the baseline EGD and between baseline EGD and randomization, or daily use of a histamine H2-receptor antagonist during the last 14 days prior to the baseline EGD (occasional use of H2-receptor antagonist less than daily is permitted during this period).
    13. Need for continuous concurrent therapy with:
    - Prostaglandin analogues
    - Sucralfate.
    14. Any condition that, in the opinion of the investigator, may either put the subject at risk or influence the result of the study (eg, cardiogenic shock or severe haemodynamic instability, risk for non-compliance, risk for being lost to follow-up), as judged by the investigator.
    15. Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
    16. Alcohol and/or drug abuse or any other condition associated with poor compliance, as judged by the investigator.
    17. Use of any other investigational compound or participation in another clinical study within the last 30 days prior to randomization.
    18. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the study site).
    19. Previous enrolment or randomization in the present study.
    E.5 End points
    E.5.1Primary end point(s)
    Development of a gastric and/or a duodenal ulcer.
    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 No
    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 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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 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
    End of study is defined as database lock, which is the time point after which no subjects 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 months6
    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 months6
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 2400
    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 Decision2007-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
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