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Daily Four Times or Two Times Usage of PPI and Amoxicillin for the First or Second Line H. Pylori Eradication

NCT03802318 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2019-01-14

No results posted yet for this study

Summary

The hypothesis and plan of the current study are:

1. One induction phase of high dose PPI before eradication will increase intragastric pH and induce H. pylori into an active replicative status. Active replicative status will enhance the bactericidal effect of amoxicillin. Rabeprazole (20 mg) four times per day (qid) for 3 days will be used for induction in this study.
2. High dose PPI will provide adequate plasma concentration irrespective of the CYP2C19 genotype of the population. Here rabeprazole (20 mg) qid will be applied as high dose PPI.
3. High frequent amoxicillin usage (500 mg, qid) will maintain plasma concentration above the MIC. Amoxicillin (500 mg) qid will be described for total 14 days.
4. In the rescue therapy, add levofloxacin on high dose dual therapy will increase the eradication rate than single high dose dual therapy. A combination of levofloxacin and high dose dual therapy will also have a better eradication rate than the common used levofloxacin based triple therapy.

Conditions

  • Helicobacter Pylori Infection
  • Helicobacter Gastritis
  • Helicobacter-Associated Pyloric Ulcer

Interventions

DRUG

Rabeprazole

Rabeprazole daily four time (Bid) or daily four times (Qid) Amoxicillin used daily two times (1000 mg bid) or daily four times (500 mg qid) apply in the first line or the second line H pylori eradication therapy

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Ming-Jui Hung, PhD · Chang-Gung Memorial Hospital at Keelung

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Taiwan

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 NCT03802318 on ClinicalTrials.gov