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Concomitant Versus Hybrid Regimen for H. Pylori Eradication

NCT03592069 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2021-08-31

No results posted yet for this study

Summary

10 day concomitant versus 14 day hybrid regimen as first line H. pylori eradication treatment in a high clarithromycin resistance area. A multicenter, randomized, equivalence trial.

Conditions

  • H.Pylori Infection
  • H.Pylori Gastrointestinal Disease
  • H. Pylori Associated Phlegmonous Gastritis

Interventions

DRUG

10 day concomitant regimen

10 Day Concomitant Hp therapy Concomitant for 10 days, including 40 mg of esomeprazole bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid

DRUG

14 day hybrid regimen

14 Day Hybrid Hp therapy Hybrid for 14 days, including 40 mg of esomeprazole bid and amoxicillin 1g bid, for the first 7 days followed by esomeprazole 40mg bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid, for another 7 days.

Sponsors & Collaborators

  • Hellenic Society of Gastroenterology

    collaborator UNKNOWN

  • Alexandra Hospital, Athens, Greece

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2020-10-21
Completion
2021-01-31

Countries

  • Greece

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 NCT03592069 on ClinicalTrials.gov