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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-019064-36
    Sponsor's Protocol Code Number:MA-PY-Hp09-01
    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:2012-02-03
    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 number2010-019064-36
    A.3Full title of the trial
    Efficacy and Safety of PYLERA™ (Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride) With Omeprazole Given x 10 Days in Subjects Who Failed Treatment for Eradication of Helicobacter pylori
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of PYLERA™ (Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride) With Omeprazole Given x 10 Days in Subjects Who Failed Treatment for Eradication of Helicobacter pylori
    A.4.1Sponsor's protocol code numberMA-PY-Hp09-01
    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 SponsorAptalis Pharma Canada Inc.
    B.1.3.4CountryCanada
    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 supportAptalis Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAptalis Pharma SAS
    B.5.2Functional name of contact pointMr Gilles CHAUVIERE
    B.5.3 Address:
    B.5.3.1Street AddressRoute de Bû
    B.5.3.2Town/ cityHoudan
    B.5.3.3Post code78550
    B.5.3.4CountryFrance
    B.5.4Telephone number33130461900
    B.5.5Fax number33130596547
    B.5.6E-mailgchauviere@aptalispharma.com
    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 PYLERA
    D.2.1.1.2Name of the Marketing Authorisation holderAptalis Pharma US Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namePYLERA
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNTetracycline hydrochloride
    D.3.9.1CAS number 64-75-5
    D.3.9.3Other descriptive nameTETRACYCLINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04760MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETRONIDAZOLE
    D.3.9.1CAS number 443-48-1
    D.3.9.4EV Substance CodeSUB08922MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 880149-29-1
    D.3.9.3Other descriptive nameBISMUTH SUBCITRATE POTASSIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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) Yes
    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 Yes
    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 LOSEC
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameOmeprazole
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNOMEPRAZOLE
    D.3.9.1CAS number 73590-58-6
    D.3.9.3Other descriptive nameOMEPRAZOLE
    D.3.9.4EV Substance CodeSUB09439MIG
    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) 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
    Eradication of Helicobacter pylori
    E.1.1.1Medical condition in easily understood language
    Eradication of Helicobacter pylori
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019377
    E.1.2Term Helicobacter pylori infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the rate of Helicobacter pylori (H. pylori) eradication following quadruple therapy with bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride, given with omeprazole in H. pylori infected subjects, who failed one course of omeprazole-amoxicillin-clarithromycin (OAC) eradication therapy
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of antibiotic resistance of H. pylori on the efficacy of treatment with PYLERA™.
    2. To assess the safety and tolerability of this therapeutic regimen with respect to subject-reported and investigator-observed adverse events, and clinical laboratory abnormalities.
    3. To compare eradication outcomes in subjects with presence/past history of peptic ulcers at baseline versus those without.
    4. To assess compliance to treatment.
    5. To identify potential treatment success drivers in OAC-refractory subjects, including age, in vitro resistance, type and number of treatments, and comorbidities.
    6. To evaluate resource utilization associated with treatment failure from twelve months prior to baseline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or non-pregnant, non-nursing women, 18 years of age and older.
    2. Women of childbearing potential must use a medically acceptable birth control method for the duration of the study (i.e. from Screening) and for 30 days thereafter. Women who are not of childbearing potential will be defined as postmenopausal (no presence of menses for at least 12 months if > 50 years of age, or no presence of menses for 24 months if ≤ 50 years of age), surgically sterilized (tubal ligation for at least 6 months, ovariectomy or hysterectomy) or
    diagnosed infertile.
    3. Positive for H. pylori status using both 13C-urea breath test (UBT) and rapid urease test (RUT).
    4. Documented eradication failure to one prior course of OAC treatment, one prior course of OAC treatment and one supplemental treatment, one prior course of OAC treatment and two supplemental treatments, or one prior course of OAC treatment and three supplemental treatments.
    5. Presence of upper gastrointestinal symptoms.
    6. Mental and legal ability to give written informed consent.
    E.4Principal exclusion criteria
    1. Previous use of bismuth, metronidazole and tetracycline combination therapy for H. pylori eradication.
    2. Previous surgery of the upper gastrointestinal tract (except cholecystectomy).
    3. Presence or history of clinically significant impairment of renal function, hepatic function, or liver disease.
    4. Presence or history of severe or unstable cardiovascular, pulmonary or endocrine disease.
    5. Presence or history of Zollinger Ellison Syndrome.
    6. Any current or recent (within 1 month of screening) hematemesis, melena, or documented gastrointestinal bleeding or iron-deficiency anaemia of clinical significance.
    7. Malignant disease of any kind except for successfully treated skin cancer (basal or squamous cell) during the previous 5 years.
    8. Barrett’s esophagus or high-grade dysplasia.
    9. Dysphagia or vomiting as major symptoms.
    10. Drug, alcohol or medication abuse within the past year.
    11. Continuous use of anti-ulcer drugs, including H2-receptor antagonists, sucralfate and prostaglandins during the 2 weeks preceding the 13C-UBT at screening.
    12. Continuous use of PPI in the 2 weeks preceding the 13C-UBT at screening.
    13. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) except acetylsalicylic acid 100 mg or less daily.
    14. Requirement for anticoagulants/platelet aggregation inhibitors except for cardiovascular disease prevention (for example acetyl-salicylic at a dose not exceeding 100 mg daily) and systemic glucocorticoids (because of association with ulcer disease).
    15. Use of systemic antibiotics in the 30 days prior to screening
    16. Regular use (> 3 times per week) of bismuth compounds in the 30 days prior to screening.
    17. Presence of a contraindication or hypersensitivity to the use of any of the active ingredients or excipients contained within the provided study medications: Omeprazole: subjects with rare hereditary problems of galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsoption; Bismuth; Metronidazole: active neurological disorder, history of blood dyscrasia, uncorrected hypothyroidism, uncorrected hypoadrenalism, alcoholism, concomitant use of disulfiram or use of disulfiram within the previous two weeks (can cause psychotic reactions); Tetracycline; Maalox® Plus: subjects with rare hereditary problems of fructose intolerance.
    18. Use of any experimental drug or experimental device within the 30 days prior to screening and throughout the entire study.
    19. Known hypersensitivity to or previous adverse experience(s) with citric acid or any of the study medications.
    20. Subject known to be positive for human immunodeficiency virus (HIV), hepatitis, or other diseases transmissible by blood or biopsy samples.
    21. Any concern by the Investigator regarding the safe participation of the subject in the study or for any other reason the Investigator considers the subject inappropriate for participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Eradication rate, defined as one negative 13C-UBT performed at least 28 days post treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at least 28 days post treatment.
    E.5.2Secondary end point(s)
    1. Subgroup analysis evaluating H. pylori eradication rate in subjects with antibiotic-resistant strains of H. pylori.
    2. Subgroup analysis evaluating H. pylori eradication rate in subjects with presence/history of peptic ulcer versus those without.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Post-study analysis
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Last visit Last subject
    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 months8
    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 months8
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    There are no specific treatment or care planned after the subject has ended the participation in the trial
    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 Decision2012-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-18
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