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    Summary
    EudraCT Number:2012-000064-24
    Sponsor's Protocol Code Number:AB2012-UBT01
    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:2012-07-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-000064-24
    A.3Full title of the trial
    Comparative assessment of diagnostic performance of C13-Urea Breath Test (BREATHQUALITY-UBT, oral solution C13-Urea 75 mg/10 mL) with 10 min protocol vs standard 30 min protocol to determinate the Helicobacter pylori infection in patients with upper gastrointestinal symptoms and in monitoring eradication therapy.
    Valutazione comparativa dell'efficacia diagnostica del urea breath test al carbonio 13 (BREATHQUALITY-UBT, soluzione orale 13C-urea 75 mg/10 ml) con protocollo di lettura a 10 minuti vs. protocollo standard con lettura a 30 minuti nella determinazione dell infezione da Helicobacter pylori in pazienti con sintomatologia dell'apparato gastrointestinale superiore e nel monitoraggio della terapia eradicante.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of diagnostic performance of a Breath Test (BREATHQUALITY-UBT) to determinate the Helicobacter pylori infection and monitoring eradication therapy with a protocol shortened to 10 min by comparison with standard 30 min protocol and with another test authorized in the European market.
    Studio dell'efficacia diagnostica di un test dell'espirato (BREATHQUALITY-UBT) per la determinazione dell’infezione da Helicobacter pylori e per il controllo dell’efficacia della terapia di eradicazione con protocollo abbreviato a 10 min mediante confronto dei risultati tra protocollo standard con prelievo dell’espirato a 30 min e con un altro test autorizzato sul mercato europeo.
    A.4.1Sponsor's protocol code numberAB2012-UBT01
    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 SponsorAB ANALITICA SRL
    B.1.3.4CountryItaly
    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 supportAB ANALITICA SRL
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPoliclinicoS.Orsola-Malpighi
    B.5.2Functional name of contact pointDipart. Medicina Interna e Gastroen
    B.5.3 Address:
    B.5.3.1Street Addressvia Massarenti 9
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number+39-051-6364140
    B.5.5Fax number+39-051-398794
    B.5.6E-mailberardino.vaira@unibo.it
    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 BREATHQUALITY-UBT*OS FL 10ML
    D.2.1.1.2Name of the Marketing Authorisation holderAB ANALITICA Srl
    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 Oral solution
    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 INN13C-UREA
    D.3.9.1CAS number 58069-82-2
    D.3.9.4EV Substance CodeSUB20015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    D.3.11.13.1Other medicinal product typediagnostico
    D.IMP: 2
    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.2.1.1.1Trade name Helicobacter test INFAI
    D.2.1.1.2Name of the Marketing Authorisation holderINFAI GmbH
    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 Oral powder
    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 INN13C-UREA
    D.3.9.1CAS number 58069-82-2
    D.3.9.4EV Substance CodeSUB20015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typediagnostico
    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
    Presence of symptoms referable to the proximal segment of the digestive system, indicative of a possible Helicobacter pylori infection.
    Sintomatologia del tratto gastrointestinale superiore, indicazione di possibile infezione da Helicobacter pylori.
    E.1.1.1Medical condition in easily understood language
    Presence of discomfort to the stomach and duodenum, indicative of a possible Helicobacter pylori infection.
    Disturbi allo stomaco e duodeno, indicazione di possibile infezione da Helicobacter pylori.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064777
    E.1.2Term Helicobacter pylori urea breath test
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Diagnostic performance assessment of 13C-urea breath test BREATHQUALITY UBT (AB ANALITICA Srl) with a protocol of breath sampling after 10 minutes vs. the standard protocol with sampling after 30 minutes, compared to the reference method deemed ''gold standard ''(histology and urease test and / or bacterial culture). In patients infected with Helicobacter pylori, to evaluate the diagnostic efficacy, in terms of clinical sensitivity and specificity of urea breath test at carbon 13, with sampling after 10 minutes vs. standard sampling after 30 minutes in monitoring the success of eradication therapy.
    Valutazione dell'efficacia diagnostica del 13C-urea breath test BREATHQUALITY-UBT con protocollo di lettura dopo 10 min vs il protocollo standard con lettura dopo 30 min, rispetto alla metodica ''gold standard'' (istologia e test all'ureasi e/o esame colturale). Nei pazienti con infezione da H.pylori, valutazione dell’efficacia diagnostica del test con lettura dopo 10 min vs lettura standard dopo 30 min per il monitoraggio del successo della terapia eradicante.
    E.2.2Secondary objectives of the trial
    Comparative assessment of clinical data sensitivity and specificity of two 13C-urea breath test: BREATHQUALITY-UBT (AB ANALITICA Srl) and Helicobacter Test INFAI (INFAI GmbH) in the determination of gastro-duodenal infection by Helicobacter pylori and monitoring of eradication therapy.
    Valutazione comparativa dei dati di sensibilità e specificità cliniche di BREATHQUALITY-UBT vs Helicobacter test INFAI (INFAI GmbH)nella determinazione dell’infezione gastro-duodenale da H.pylori e nel monitoraggio della terapia eradicante.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)presence of symptoms referable to the proximal segment of the digestive system (nausea, epigastralgy, retrosternal pyrosis, maldigestion, meteorism) 2)Patients with unknown H. pylori status 3)Patients aged 18 years. 4)Patients able to give informed consent.
    1) presenza di sintomi riferibili ai tratti prossimali dell'apparato digerente (nausea, epigastralgia, pirosi retrosternale, mal digestione, meteorismo) 2)Pazienti d cui non si conosce lo status H.pylori 3)Pazienti di età superiore ai 18 anni. 4)Pazienti in grado di dare il proprio consenso informato.
    E.4Principal exclusion criteria
    1) Patients who have had major abdominal surgery (appendectomy and colecystectomy are admitted). 2) Patients who are on chronic treatment with antisecretory drugs (4 months / years) and/or steroidal and non-steroidal anti-inflammatory drugs (1 week / month), 3) patients with disorders of the gastro-intestinal physiology (eg, Zollinger-Ellison syndrome) 4) Patients who received antisecretory drugs in the last 4 weeks, antibiotics or bismuth salts. 5) Patients already receiving eradication therapy vs. H. pylori. 6) Patients carrying coagulopathies and other conditions for which it is contraindicated to perform endoscopy and biopsy. 7) Severe renal failure 8) Pregnancy and lactation 9) Presence of ''alarm symptoms'' (melena, weight loss, anemia, haematemesis).
    1) Pazienti che hanno subito interventi chirurgici addominali di rilievo (si ammette appendicectomia e colecistectomia). 2)Pazienti che sono in trattamento cronico con farmaci antisecretivi (4 mesi/anno) e/o antiinfiammatori steroidei e non steroidei (1 settimana/mese), 3) pazienti con Sindrome di Zollinger-Ellison. 4) Pazienti che hanno assunto nelle ultime 4 settimane farmaci antisecretivi, antibiotici o sali di bismuto. 5) Pazienti già sottoposti a terapia eradicante vs H. pylori. 6) Pazienti portatori di coagulopatie e altre patologie per le quali è controindicato eseguire l'endoscopia e i prelievi bioptici. 7) Severa insufficienza renale 8) Gravidanza e allattamento 9) Presenza di “sintomi d'allarme” (melena, calo ponderale, ematemesi).
    E.5 End points
    E.5.1Primary end point(s)
    Calculation of test sensitivity and specificity with shortened protocol (10 min) vs. the standard protocol (30 min) with reference to ''gold standard'' method to evaluate the H.pylori infection and to monitoring the eradication therapy.
    Calcolo dei parametri di sensibilità e specificità del test con protocollo abbreviato (10 min) in confronto al protocollo standard (30 min) e in riferimento al''gold standard'' per la determinazione dell'infezione da H.pylori e per il monitoraggio della terapia eradicante.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    Comparative assessment of diagnostic performances of the test vs. another test authorized in the European Market (Helicobacter test INFAI)
    Valutazione comparativa delle performances diagnostiche del test in confronto ad un altro test presente sul mercato Europeo (Helicobacter test INFAI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 Yes
    E.6.13.1Other scope of the trial description
    00
    Efficacia diagnostica del test con protocollo breve (10 min) , confronto con altro test
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    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 months12
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 2012-07-23. Yes
    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 state200
    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)
    not applicable
    non applicabile
    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 Decision2012-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-30
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