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    Summary
    EudraCT Number:2007-006280-78
    Sponsor's Protocol Code Number:PYLHp07-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-006280-78
    A.3Full title of the trial
    Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 days
    Efficacia e sicurezza della quadrupla terapia a base di pottasio di bismuto subcitrato,metronidazolo e tetraciclina somministrati per 10 giorni con omeprazolo nell`eradicazione dell`Helicobacter pylori:confronto con omeprazolo,amoxicillina e claritromicina somministrati per 7 giorni
    A.3.2Name or abbreviated title of the trial where available
    PYLHp07-01
    PYLHp07-01
    A.4.1Sponsor's protocol code numberPYLHp07-01
    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 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 Yes
    D.2.1.1.1Trade name Pylera
    D.2.1.1.2Name of the Marketing Authorisation holderAxcan Pharma
    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.3.4Pharmaceutical 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+metronidazole+bismuth subcitrate potassium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNAmoxicillin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number500
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClarithromycin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number500
    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
    Helicobacter Pylori infection
    Infezione con Helicobacter Pylori
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10051790
    E.1.2Term Helicobacter pylori gastritis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the rate of Helicobacter pylori eradication following quadruple therapy by a Single-Triple capsule of bismuth subcitrate potassium, metronidazole, and tetracycline, given with omeprazole (OBMT) vs omeprazole, amoxicillin and clarithromycin (OAC) in Helicobacter pylori positive patients.
    Confrontare il tasso di eradicazione dell`Helicobacter Pylori dopo quadrupla terapia a base di una capsula tre in uno di potassio di bismuto subcitrato,metronidazolo e tetraciclina somministrata con omeprazolo rispetto a terapia con omeprazolo,amoxicillina e claritromicina in pazienti positivi per l`Helicobacter Pylori
    E.2.2Secondary objectives of the trial
    1. To compare eradication outcomes in patients with presence/past history of peptic ulcers at baseline vs those without. 2. To evaluate the effect of resistance of Helicobacter pylori to metronidazole and clarithromycin on the efficacy of these treatments. 3. To evaluate the rate of secondary resistance induced by these treatments. 4. To assess the safety and tolerability of these therapeutic regimens with respect to patient-reported and investigator-observed adverse events, clinical laboratory abnormalities and plasma bismuth (Bi) concentrations. 5. To evaluate compliance to treatment
    1.Confrontare i risultati relativi all`eradicazione in pazienti con ulcera peptica attuale o pregressa alla baseline rispetto a pazienti senza ulcera peptica.2.Valutare l`effetto della resistenza dell`Helicobacter Pylori al metronidazolo e all claritromicina sull`efficacia di tali trattamenti 3.Valutare il tasso di resistenza secondaria indotto da tali trattamenti 5.Valutare l`osservanza del trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    maschi o femmine non incinte 18 anni e piu positivi per HP da C-13 UBT e almeno 2 da 3 test positivi tra rapid urease test,istologia e /o coltura
    male or non pregnant 18 years and older positive for Helicobacter Pylori by C-13 UBT and at least 2 of 3 positive results among rapid urease test, histological examination and /or culture presence of upper GI symptoms
    E.4Principal exclusion criteria
    • Previous surgery of the upper gastrointestinal tract (except appendectomy, polypectomy, or cholecystectomy) • Presence or history of clinically significant impairment of renal function, hepatic function, or liver disease • Presence or history of severe or unstable cardiovascular, pulmonary or endocrine disease • Presence or history of Zollinger Ellison Syndrome • Any current or recent (within 1 month of screening) hematemesis, melena, or documented gastrointestinal bleeding or iron-deficiency anaemia of clinical significance • Malignant disease of any kind except for successfully treated skin cancer (basal or squamous cell) during the previous 5 years • Barrett's esophagus or high-grade dysplasia • Dysphagia or vomiting as major symptoms • Drug, alcohol or medication abuse within the past year • Continuous use of anti-ulcer drugs, including H2 receptor antagonists, sucralfate and prostaglandins during the 2 weeks preceding the C 13 UBT at screening • Continuous use of proton pump inhibitor in the 2 weeks preceding the C 13 UBT at screening • Chronic use of NSAIDs, except for acetyl-salicylic acid 100 mg or less daily • Requirement for anticoagulants (except for acetyl-salicylic acid 100 mg or less daily) and glucocorticoids (because of association with ulcer disease) • Use of antibiotics in the month before randomization • Regular use (> 3 times per week) of bismuth compounds in the month before randomization. • Presence of a contraindication to the use of metronidazole: e.g. active neurological disorder, history of blood dyscrasia, uncorrected hypothyroidism, uncorrected hypoadrenalism, or alcoholism, tetracycline (known sensitivity to tetracyclines), clarithromycin (known hypersensitivity to macrolides, use of cisapride, pimozide, terfenadine, astemizole and ergotamine/dihydroergotamine), amoxicillin (known sensitivity to penicilins), or omeprazole (known sensitivity to omeprazole). • Use of any experimental drug within the 30 days prior to randomization. • Previous attempt by a recognized antibiotic treatment to eradicate an adequately documented infection by Helicobacter pylori. • Known hypersensitivity to or previous adverse experience(s) with citric acid or any of the study drugs. • Patient known to be positive for HIV, hepatitis, or other diseases transmissible by blood or biopsy samples.
    -previe operazioni sul tratto GI superiore(eccetto apendectomia,polipectomia,cholecistectomia) -presenza o anamnesi di malfunzione di reni o fegato ematemesi, melena,o emoraggia GI documentata attuale o recente (entro un mese dallo screening0 o anemia sideropenica clinicamente rilevante -Esofago di Barrett o displasia di alto grado -disfagia o vomito come sintomi maggiori -precedente tentativo di eradicazione di HP, adeguatamente documentata, per mezzo di un trattamento antibiotico riconosciuto
    E.5 End points
    E.5.1Primary end point(s)
    Eradication rate, defined as two negative C-13 urea breath tests performed at 6 and 10 weeks following initiation of therapy.
    Tasso di eradicazione, definita come esito negativo di due test del respiro all`urea marcata C-13 eseguiti alla sesta e alla decima settimana dall`inizio della terapia
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Ultima visita del ultimo soggetto oppure a discrezione dello promotore, specialmente se si tratta di proteggere la sicurezza dei pazienti
    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 months15
    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 months15
    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.1.1.2Preterm 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.1.3Elderly (>=65 years) No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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 Decision2008-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-30
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