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    The EU Clinical Trials Register currently displays   35554   clinical trials with a EudraCT protocol, of which   5841   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-000257-22
    Sponsor's Protocol Code Number:D9612L00104
    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:2006-05-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-000257-22
    A.3Full title of the trial
    A study to assess the effectiveness of esomeprazole 40 mg once daily in subjects with continuing gastroesophageal reflux disease (GORD) symptoms following treatment with a previous full dose proton pump inhibitor (PPI). An 8 week, open label, multicentre study.
    A.3.2Name or abbreviated title of the trial where available
    RESPONSE study
    A.4.1Sponsor's protocol code numberD9612L00104
    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 UK 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 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 (esomeprazole)
    D.3.2Product code Nexium (esomeprazole)
    D.3.4Pharmaceutical form 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 161796-78-7
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    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 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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeTablet for oral administration
    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
    Gastroesophageal Reflux Disease (GORD)
    MedDRA Classification
    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 this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with Esomeprazole 40mg compared to previous full dose treatment with a PPI given once daily.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the:
    - Change in frequency of heartburn after 4 weeks treatment from baseline value at entry into the study
    - Change in severity of heartburn after 4 and 8 weeks treatment from baseline value at entry into the study
    - Change in severity and frequency of epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline values at entry into the study.
    - Change in symptom control on Esomeprazole 40mg from baseline to 4 and 8 weeks using the Reflux Disease Questionnaire (RDQ)
    - Symptom control, defined as more symptom free days, as assessed by the GORD Impact Scale (GIS) at weeks 4 and 8.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Signed and dated informed consent will be obtained before any study related procedure is conducted.
    2. Male or female aged ³ 18 years
    3. Current treatment for GORD with a PPI at a full dose, given once daily, for a period of up to 8 weeks
    4. Persisting GORD symptoms of heartburn, acid regurgitation or epigastric pain during the past 7 days prior to visit 1, judged by the subject as either:
    · 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)
    · 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)
    E.4Principal exclusion criteria
    presence of one or more of these criteria will exclude the patient

    1. More than 1 previous course of full dose PPI in the last 12 months (excluding the current course)
    2. Current treatment for GORD with a full dose PPI for more than 8-weeks
    3. Previous use of esomeprazole
    4. Subjects using an H2 receptor antagonist (either prescribed or OTC)
    5. Documented medical history or gastrointestinal pathology such as:
    · Gastrointestinal malignancy
    · Zollinger-Ellison syndrome; malabsorption
    · Significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator to interfere with the evaluation of the study
    · Unstable diabetes mellitus as judged by the investigator to interfere with the evaluation of the study

    6. Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or pyloroplasty, hiatus hernia surgery or fundoplication. Note: Previous lower gastrointestinal surgery such as appendectomy, colonic resection, cholecystectomy, or gynaecological surgery are not exclusion criteria

    7. Presence of Irritable Bowel Syndrome as judged by the investigator. This is characterised by chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating·
    8. Presence of any alarm symptoms suggestive of organic disease, including but not limited to, vomiting, GI bleeding or anaemia, abdominal mass, unexplained weight loss and dysphagia
    9. Severe, concurrent disease or mental illness that may complicate the study evaluation or affect subject compliance as judged by the Investigator
    10. Requirement for continuous concurrent therapy with the following medications during the study period:
    Sucralfate, quinidine, warfarin and other vitamin K antagonists, phenytoin, bisphosphonates, methotrexate, antidepressants (therapy less than 3 days per week is acceptable), prostaglandin analogues such as misoprostol, ketoconazole, fluconazole, itraconazole, diazepam, cisapride

    11. Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test and maintain contraception during the study medication treatment period. Investigators should be satisfied that those women who are not surgically sterilized or are < 1 year post-menopausal are not pregnant at study entry. Any contraceptive measure with a less than 1% failure rate will be considered acceptable (birth control pill, IUD, Depo-Provera®) or double-barrier method (e.g. condom and spermicide, diaphragm and contraceptive foam).
    12. Chronic alcoholism, drug abuse, or psychological condition judged by the investigator to potentially result in poor subject compliance or interfere with study evaluation.
    13. Suspected or confirmed current malignancy except basal cell carcinoma. Current is defined as: any malignancy, except basal cell carcinoma, that has been active within the previous 12 months
    14. Known hypersensitivity to esomeprazole or any of its constituents
    15. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    16. Previous enrolment or randomisation of treatment in the present study.
    17. Participation in a clinical study during the last 90 days.
    E.5 End points
    E.5.1Primary end point(s)
    Change in frequency of heartburn from baseline value at entry to the end of the study.
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    The end of study is defiined as database lock, which is the timepoint 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 years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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 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 2006-05-05. 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 No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.6.1Details of subjects incapable of giving consent
    Women of childbearing potential must have negative pregnancy test and maintain contraception during the study medication treatment period.
    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 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2006-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-11
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