E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Helicobacter Pylori infection |
Infezione con Helicobacter Pylori |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051790 |
E.1.2 | Term | Helicobacter pylori gastritis |
E.1.2 | System Organ Class | 100000004862 |
|
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 |
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.2.2 | Secondary 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.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.4 | Principal 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.5.1 | Primary 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.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | No |
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
|
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.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 15 |
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 | 15 |
E.8.9.2 | In all countries concerned by the trial days | 0 |