First-line eradication treatment of Helicobacter pylori infection: clinical trial without placebo, randomized, multi-center and three parallel treatment groups comparing classic triple therapy versus modified sequential therapy and other concomitant therapy.

Conditions: Clinical situations where it is recommended the eradication of Helicobacter pylori: - Gastric or duodenal ulcer (active or not) and duodenal erosions - Gastric MALT lymphoma - First-degree relatives of patients with gastric cancer - Intestinal metaplasia with high-risk histologic criteria - Functional dyspepsia whose clinical symptom persists despite treatment with proton pump inhibitors (PPIs) and / or prokinetic
MedDRA version: 14.1Level: LLTClassification code 10019377Term: Helicobacter pylori infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Registration Number: EUCTR2011-006258-99-ES

Lead Sponsor: Sección de Digestivo. Hospital Comarcal de Laredo

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

Inclusion Criteria

1) All cases of gastric or duodenal ulcer (active or not) and duodenal erosions
2) Patients diagnosed with gastric MALT lymphoma
3) First-degree relatives of patients with gastric cancer
4) Intestinal metaplasia with high-risk histological criteria
5) Patients with functional dyspepsia with persistent clinical symptomatic despite treatment with inhibitors of the proton pump (IBP) and / or prokinetic
6) Patients which had given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1) Age less than 18 or older than 75 years
2) Advanced chronic disease
3) Allergy to any medicines included in this study
4) Previous gastric surgery
5) Prior eradication treatment
6) Pregnancy and lactation
7) Administration of bismuth or antibiotics within the previous 4 weeks
8) Administration of H2 antagonists or inhibitors of the proton pump (IBP) in the 2 weeks prior to study entry

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy of eradication treatment of Helicobacter pylori. Proportion of eradication of H. pylori assessed at least 4 weeks after treatment is completed by the breath test, or alternatively, by urease test or histology when revision endoscopy is necessary;Secondary Objective: Assessment of tolerability (safety) of treatment and monitoring the potential adverse effects;Primary end point(s): Efficacy in the eradication of antibiotic treatment in patients infected with Helicobacter pylori by breath test or histology, urease test or endoscopy if you need review;Timepoint(s) of evaluation of this end point: 4 weeks after the end of the eradication treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Checkingl the tolerability and safety of different treatments, ruling out serious adverse events;Timepoint(s) of evaluation of this end point: At least one month follow-up after completion of treatment, further follow-up will be scheduled if needed