E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Helicobacter pylori infection |
Infección por Helicobacter pylori |
|
E.1.1.1 | Medical condition in easily understood language |
Helicobaccter pylori infecction |
Infección por Helicobacter pylori |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
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 |
To assess the efficacy and safety of the addition of rifaximin to a standard triple therapy (inhibitor of proton pump, amoxicillin and clarithromycin) for the eradication of H. pylori |
Evaluar la eficacia y la seguridad de la adición de Rifaximina a la terapia triple estándar (inhibidor de la bomba de protones, amoxicilina y claritromicina) para la erradicación de H. pylori |
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E.2.2 | Secondary objectives of the trial |
Demonstrate good tolerability of the addition of rifaximin to the standard triple therapy Assess adherence of the addition of rifaximin to standard triple therapy |
Demostrar la buena tolerancia de la adición de Rifaximina a la terapia triple estándar Evaluar el cumplimiento terapéutico de la adición de Rifaximina a la terapia triple estándar |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.- Age more than or equal to 18 years 2.- Dyspeptic patients with persistent or recurrent symptoms, with demonstrated H. pylori infection. 3.- Having been prescribed the standard triple therapy eradication therapy by routine clinical practice. 4.- Haven't begun taking the eradication treatment yet. 5.- Written informed consent of the patient. 6.- The five first patient included in the study must have a blood test scheduled from the outpatient clinic, in the month after the treatment is finished. 7.- If the patient is a woman of childbearing age, is asked to commit to not get pregnant or t use adequate contraception. |
1.-Edad mayor o igual a 18 años. 2. Pacientes con síntomas dispépticos persistente o recurrente, en los que se hubiera demostrado infección por H. pylori 3. Tener recetada previamente por práctica clínica habitual la triple terapia estándar como tratamiento erradicador. 4. No haber comenzado todavía la toma del tratamiento erradicador. 5. Consentimiento informado por escrito del paciente. 6. Los cinco primeros pacientes incluidos en el estudio deberán tener citada desde el ambulatorio y previamente a su llegada a consulta, una analítica rutinaria en el mes posterior a la finalización del tratamiento erradicador. 7. Si la paciente es mujer en edad fértil, se le pedirá que se comprometa a no quedarse embarazada, o bien que utilice un método anticonceptivo adecuado |
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E.4 | Principal exclusion criteria |
1.- Previouse Eradication therapy for H. pylori 2.- Allergy to any of the antibiotic used in the treatment. 3.- Taking antibiotics or bismuth salts after conducting the breath test. 4.- Previous gastric surgery. 5.- Presence of pulmonary, hepatic, renal, endocrine, metabolic, hematologic or tumoral severe disease. 6.- Very advanced chronic disease or any other condition that prevents attending to monitoring and control visits. 7.- History of drug or alcohol abuse. 8.- Patients who are pregnant or lactating. |
1.- Tratamiento de erradicación para H. pylori previo 2.- Alergia a alguno de los antibióticos del tratamiento. 3.- Toma de antibióticos o sales de bismuto desde la realización de la prueba del aliento. 4.- Cirugía gástrica previa. 5.- Presencia de enfermedad grave pulmonar, hepática, renal, endocrina, metabólica, hematológica o tumoral. 6.- Enfermedad crónica muy avanzada o cualquier otra patología que impida acudir a controles y seguimiento. 7.- Historial de abuso de alcohol o drogas. 8.- Pacientes embarazadas o en periodo de lactancia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Eradication of H. pylori "intention to treat" |
Erradicación de H. pylori por "intención de tratar" |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At least 4 weeks after completion of eradication therapy |
Al menos 4 semanas tras la finalización del tratamiento erradicador |
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E.5.2 | Secondary end point(s) |
- Helicobacter pylori eradication "per protocol". - Treatment compliance. - Medication adverse effects. - Clincal and demographic variables |
- Erradicación de Helicobacter pylori "por protocolo". - cumplimiento del tratamiento. - Efectos adversos de la medicación. - Variables clínicas y demográficas. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At least 4 weeks after completion of eradication therapy. |
Al menos 4 semanas tras la finalización del tratamiento erradicador. |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
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 | No |
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.8.5 | The trial involves multiple Member States | No |
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
|
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |