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    Summary
    EudraCT Number:2004-005169-39
    Sponsor's Protocol Code Number:D9914C00002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-07-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-005169-39
    A.3Full title of the trial
    A single-blind single arm study to validate the Reflux Disease Questionnaire (RDQ) for the diagnosis of reflux disease in primary care in patients treated with esomeprazole 40 mg o.d.
    A.4.1Sponsor's protocol code numberD9914C00002
    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 Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEsomeprazole, phase III capsule
    D.3.2Product code Esomeprazole, Gastro-Resistant Capsules
    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.3.10 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 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
    Symptoms from the upper gastrointestinal tract
    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 determine the accuracy of the RDQ as a diagnostic test for gastroesophageal reflux disease. Symptom evaluation by the RDQ will be compared with other established approaches to the diagnosis of GERD in a primary care patient population with symptoms thought to be of upper gastrointestinal (GI) tract origin.
    E.2.2Secondary objectives of the trial
    1. To estimate the sensitivity and specificity of the selection of RDQ items, endoscopy, esophageal pH monitoring, response to proton pump inhibitors (PPIs) and Symptom Association Probability (SAP) as diagnostic tests for GERD by using Latent Class Analysis (LCA) and Bayesian statistics
    2. To estimate the prevalence of GERD with LCA and Bayesian statistics
    3. To describe the study population at the initial and last visit with the Gastrointestinal Symptom Rating Scale (GSRS) dimensions in the whole study population and by GERD diagnosis
    4. To estimate responsiveness of the RDQ during therapy in subjects categorised as having or not having GERD
    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. Subjects must have provided informed consent in writing for the participation in this study
    2. Subjects aged 18 to 79 years inclusive, male or female
    3. Subjects who seek medical advice in primary care for symptoms thought by the PCP to arise from the upper GI tract (any of those symptoms listed in Table 3)
    4. The symptoms thought to pertain to the upper GI tract must have been present for at least 4 weeks prior to Visit 1 and to have occurred at least twice a week during that period
    5. The symptoms thought to pertain to the upper GI tract must have been of at least mild severity for a minimum of 3 days during the week prior to Visit 1
    6. Subjects judged to be capable to understand and to complete diaries and questionnaires reliably.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Upper GI endoscopy performed within a year prior to Visit 1
    2. Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastrointestinal resective surgery
    3. Contra-indication to the Bravo™ procedure such as subjects with a history of bleeding diathesis, strictures anywhere along the GI-tract, esophageal varices, obstructions, or subjects equipped with a pacemaker, an implantable cardiac defibrillator or an implantable neurostimulator (NB: subjects with LA Grade D confirmed by endoscopy at Visit 2 can continue the study without performing the Bravo™ procedure)
    4. Any use of PPIs within 2 months prior to Visit 1, including those obtained OTC
    5. Use of the following drug therapy within 4 weeks prior to Visit 1:
    - Daily use of acetylsalicylic acid (ASA) at any dose greater than 165 mg
    - Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) including
    COX-2 inhibitors at any dose
    6. Presence of any alarm features, such as:
    - Unintentional weight loss >3 kg in the previous 3 months
    - Haematemesis, melaena or per-rectum blood loss in the previous year
    - Progressive dysphagia
    - Anaemia
    - Any other symptom suggestive of malignancy
    7. Any significant past or current disease or disorder (e.g.; cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, malignant, or psychiatric), as revealed by history, physical examination or laboratory assessments, which, in the opinion of the investigator, may put the subject at risk, alter their performance or influence the subject’s ability to participate in the study
    8. Unwillingness to undergo endoscopy, esophageal pH monitoring or to complete any other standard assessments used in the study
    9. History of alcohol or drug abuse in the last two years or any condition associated with poor compliance, including expected non-cooperation, as judged by the investigator
    10. Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period, as judged by the investigator
    11. Treatment with phenytoin, warfarin (or other vitamin K antagonists), ketoconazole, itraconazole and cisapride
    12. Planned donation of blood during the study period
    13. Planned hospitalisation during the study period
    14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    15. Treatment with any medicinal investigational product within 30 days prior to Visit 1 or within another time-frame according to local requirements, if applicable
    16. Previous enrolment in the present study
    17. Participation as a subject in any other medical research project during and in the 4 weeks prior to the start of the study
    In addition to the above, the following criterion excludes the subject from participation into the study at Visit 2:
    18. Any findings at endoscopy that make further participation in the study clinically inappropriate as judged by the investigator, such as suspected malignancy or evidence of clinically significant gastrointestinal bleeding (i.e. visible vessel or other stigmata of current bleeding) [NB: Subjects with macroscopic Barrett’s esophagus (defined as subjects with endoscopic indications of any columnar lined epithelium in the esophagus) are not to be excluded; Subjects with LA Grade D confirmed by endoscopy at Visit 2 can continue the study without performing the Bravo™ procedure.].
    E.5 End points
    E.5.1Primary end point(s)
    There are no primary end point in this study.

    Based on the selection of RDQ items and the various methods of diagnosing
    GERD, i.e. presence/absence of GERD as assessed by endoscopic Los Angeles (LA) grade, pH monitoring (% time with esophageal pH<4), SAP, outcome of PPI test, the primary variables are the cut-off level(s), sensitivity, specificity and predictive abilities of the RDQ score(s) (ROC curve and c-statistic), as assessed against each other diagnostic tool in use in this study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Validation of the Reflux Disease Questionnaire
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Single arm
    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 date of 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 years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 2005-07-07. 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.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 350
    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 Decision2005-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-22
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