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    Summary
    EudraCT Number:2017-001369-25
    Sponsor's Protocol Code Number:HPT30/J/17
    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:2018-02-01
    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 number2017-001369-25
    A.3Full title of the trial
    The Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal with 13C-Urea Breath Test in Helicobacter Pylori Positive and Negative Patients with Dyspepsia and GERD Taking Proton Pump Inhibitors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate a new test meal for the determination of sensitivity and specificity of a 13 C -Urea H. pylori test
    A.4.1Sponsor's protocol code numberHPT30/J/17
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorINFAI Institut für biomedizinische Analytik und NMR Imaging GmbH
    B.1.3.4CountryGermany
    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 supportInfai GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInfai GmbH
    B.5.2Functional name of contact pointManaging Director
    B.5.3 Address:
    B.5.3.1Street AddressRiehler Straße 36
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50668
    B.5.3.4CountryGermany
    B.5.6E-mailsa@infai.de
    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 Yes
    D.2.1.1.1Trade name Helicobacter Test INFAI
    D.2.1.1.2Name of the Marketing Authorisation holderINFAI Institut für biomedizinische Analytik & NMR Imaging GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code V04CX
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    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 Yes
    D.2.1.1.1Trade name Nexium mups 40 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    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
    Diagnosis of Helicobacter pylori infection for patients taking proton pump inhibitors (PPI) with one day break of
    medication instead of two weeks prior to the test
    E.1.1.1Medical condition in easily understood language
    Diagnosis of Helicobacter pylori infection in patients taking medication without being able to stop Treatment longer than for one day.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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
    To confirm the sensitivity and specificity of the 13C-UBT using the new test meal for H. pylori in patients with dyspepsia and GERD taking PPI.
    E.2.2Secondary objectives of the trial
    To compare the sensitivity and specificity of the 13C-UBT using the new test meal and standard test meal for H. pylori in patients with dyspepsia and GERD taking PPI.

    To correlate the results of the Helicobacter Test INFAI® using new test meal for H. pylori in patients with dyspepsia and GERD taking PPI with:

    • Histology score for H. pylori in antrum and corpus using the updated Sydney System,
    • Sex,
    • Age,
    • Body Mass Index (BMI).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female patients of at least 18 years of age
    • All acid-related disorders requiring long-term PPI treatment including functional dyspepsia and GERD according Rome IV classification
    • Positive or negative standard 13C-UBT at screening.
    • Diagnosis of H. pylori infection confirmed or excluded by combination of culture#, histology* and rapid** urease test (PyloriTek®, Serim Research Corp., Elkhart, USA) on samples obtained by endoscopy:
    - True positive: culture and/or (histology and rapid urease test) are positive
    - True negative: at least two tests are negative and culture is not positive
    - True negative: culture not evaluable and both histology and urease test are negative.

    - Patients will undergo upper endoscopy. Six biopsy samples will be obtained during this procedure.
    #) Culture will be based on antrum and corpus 2 biopsies.
    *) two biopsies ( corpus and antrum ) for histology
    **) two biopsies ( corpus and antrum ) for Rapid urease test(RUT)

    • Written informed consent of the patient.
    E.4Principal exclusion criteria
    • Previous H. pylori eradication therapy.
    • Intake of PPI in 2 weeks, H2 receptor antagonists 1 day and NSAIDs, antibiotics, anti¬secretory drugs, bismuth compounds, or sucralfate in the 4 weeks prior to enrolment.
    • Manifest coagulopathy or any other disorder according to which endoscopy and/or biopsies are contraindicated.
    • Participation in a clinical trial with another not approved drug within 30 days before entering the study and/or previous participation in this study.
    • Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary efficacy variables:
    • The proportion of H. pylori positive patients with positive new test result using a cut-off value of 2.5‰
    • The proportion of H. pylori negative patients with negative new test result using a cut-off value of 2.5‰
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30
    E.5.2Secondary end point(s)
    • The proportion of H. pylori positive patients with positive standard test result using a cut-off value of 4‰
    • The proportion of H. pylori negative patients with negative standard test result using a cut-off value of 4‰
    • The delta over baseline (DOB) or Δδ-value [‰] will be calculated from the difference of the 13CO2 / total CO2 ratio 30 min after intake of the urea-13C solution and at baseline.
    • Coefficients of correlation between DOB and the histology score for H. pylori in antrum and corpus using the Updated Sydney System, sex, age and BMI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 30
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Refex
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 156
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 226
    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)
    None
    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 Decision2018-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-04
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