E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
H. pylori infection |
Infezione da Helicobacter pylori |
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E.1.1.1 | Medical condition in easily understood language |
H. pylori infection |
Infezione da Helicobacter pylori |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019377 |
E.1.2 | Term | Helicobacter pylori infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Concordance between the results obtained with the two methods |
Concordanza del risultato tra le due metodiche |
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E.2.2 | Secondary objectives of the trial |
Level of patient’s satisfaction obtained with a value subjective scale, about the molecular correlation spectrometry method (Breath ID®) and the infrared spectrometry. |
Grado di soddisfazione del paziente tramite una scala a valori soggettiva, riguardo alla metodica a spettrometria a correlazione molecolare (Breath ID®) e alla spettrometria a infrarossi. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Both sexes. 2. Age ≥ 18 years old 3. Outpatients, for whom urea breath test for H. pylori infection is indicated. 4. Written informed consent.
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1. Pazienti ambosessi. 2. Età ≥18 anni. 3. Pazienti per i quali sia indicata l’esecuzione di un test diagnostico per la determinazione dell’infezione da H. pylori. 4. Consenso espresso in forma scritta.
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E.4 | Principal exclusion criteria |
1. Therapy with antibiotics or bismuth in the 4 weeks before the enrollment; 2. Therapy with inhibitors of the proton pump in the 2 weeks before the enrollment; 3. Presence of alarm symptoms (e.g. unintentional weight loss, sideropenic anemia, gastrointestinal bleeding, dysphagia); 4. Atrophic gastritis; 5. Gastro-enteric tract neoplasia; 6. Known or suspected hypersensitivity to one or more components of EXPIROBACTER®; 7. Pregnancy or lactation; 8. Recent or suspected alcohol or drug abuse; 9. Presence of any kind of dementia or other possible causes of a progressive deterioration of the full possession of one's faculties or a psycho-physic inability that decreases the ability to take correctly the prescribed treatment; 10. Not sufficiently reliable or presence of conditions that may result in non-compliance/adherence of the patient to the protocol; 11. Concomitant involvement in another clinical trial; 12. Minor patients; 13. Patients who are unable to carry out study procedures or who have not given their written consent.
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1. Terapia con antibiotici o bismuto nelle 4 settimane precedenti all’arruolamento; 2. Terapia con inibitori di pompa protonica nelle 2 settimane precedenti all’arruolamento; 3. Presenza di sintomi d’allarme (es. perdita di peso non intenzionale, anemia sideropenica, sanguinamento gastrointestinale, disfagia); 4. Gastrite atrofica; 5. Neoplasie dell’apparato gastroenterico; 6. Allergia nota o sospetta ad uno o più componenti di EXPIROBACTER®; 7. Gravidanza o allattamento; 8. Recente storia o sospetto di abuso di alcol o di stupefacenti; 9. Presenza di una demenza di qualsiasi tipo o altre possibili cause di deterioramento progressivo della capacità di intendere e di volere o un’inabilità psico-fisica che riduca la capacità di assumere come previsto la terapia prescritta; 10. Non adeguata affidabilità o presenza di condizioni che possano determinare una non conformità/aderenza del paziente al protocollo; 11. Partecipazione ad un altro studio clinico concomitante; 12. Pazienti minorenni; 13. Pazienti che non siano in grado di seguire le procedure di studio o che non abbiano fornito il proprio consenso in forma scritta.
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E.5 End points |
E.5.1 | Primary end point(s) |
Concordance of the results given with the molecular correlation spectrometry method (Breath ID®) and with the infrared spectrometry, for the diagnosis of H. pylori infection |
Sovrapponibilità dei risultati della ricerca di H. pylori ottenuti con la metodica a spettrometria a correlazione molecolare (Breath ID®) e con la spettrometria a infrarossi |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Level of patient’s satisfaction obtained with a value subjective scale, about the molecular correlation spectrometry method (Breath ID®) and the infrared spectrometry. Safety: Adverse events will be recorded during the whole duration of the trial. |
Grado di soddisfazione del paziente tramite una scala a valori soggettiva, riguardo alla metodica a spettrometria a correlazione molecolare (Breath ID®) e alla spettrometria a infrarossi. Valutazioni di sicurezza: Saranno registrati, per tutta la durata dello studio, gli eventi avversi.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Stesso farmaco e dosaggio utilizzato con metodiche ≠ per la determinaz. dell’infezione da H.pylori |
Same drug and same dosage used in two different methods for diagnosis of Helicobacter pylori. |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |