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.

FIRST-LINE ERADICATOR THERAPY OF HELICOBACTER PYLORI INFECTION: OPEN CLINICAL TRIAL, RANDOMIZED, MULTICENTRE, THREE-ARMED, COMPARING THE CLASSICAL TRIPLE THERAPY VERSUS A MODIFIED SEQUENTIAL THERAPY AND A CURRENT THERAPY - ECAMATEHP

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006258-99-ES

Enrollment

300

Registered

2012-02-10

Start date

2012-04-02

Completion date

Unknown

Last updated

2012-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 14.1 Level: LLT Classification code 10019377 Term: Helicobac

Interventions

Trade Name: Flagyl Pharmaceutical Form: Tablet INN or Proposed INN: METRONIDAZOLE CAS Number: 443-48-1 Current Sponsor code: Metronidazole Other descriptive name: Metronidazole Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Spain

Contacts

Public ContactClinical Trial Area

IFIMAV (Instituto de Formación e Investigación Marqués de Valdecilla)

ifimav.eclinicos1@fmdv.org34942315515

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 5, 2026