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Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia

NCT04359966 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2020-04-24

No results posted yet for this study

Summary

Study is prospective randomised multicentric. The primary objective of the study is to compare the efficacy of two first-line therapy regimens and two second-line therapy regimens (ie, after failure of first-line treatment) in patients with H. pylori infection. The secondary objective of the study is to determine the primary resistance of H. pylori to antibiotics in Slovenia.

Conditions

  • Helicobacter Pylori Infection
  • Eradication Treatments

Interventions

DRUG

Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,

First line therapy

DRUG

Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg

First line therapy second arm

DRUG

Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg

Second line therapy for Helicobacter pylori infection

DRUG

Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg

Second line therapy for Helicobacter pylori infection second arm

Sponsors & Collaborators

  • KRKA

    collaborator INDUSTRY

  • Slovenian Society for Gastroenterology and Hepatology

    lead OTHER

Principal Investigators

  • BOJAN TEPES · AM DC Rogaška

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-10
Primary Completion
2023-05-31
Completion
2023-09-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359966 on ClinicalTrials.gov