NCT03802318

Brief Summary

The hypothesis and plan of the current study are:

  1. 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. 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
530

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

January 10, 2019

Last Update Submit

January 11, 2019

Conditions

Helicobacter Pylori InfectionHelicobacter GastritisHelicobacter-Associated Pyloric Ulcer

Keywords

Helicobacter pyloriProton pump inhibitorAmoxicillinUrea breath testLevofloxacinClarithromycin

Outcome Measures

Primary Outcomes (1)

  • H. pylori eradication rate

    Two to three months after eradication therapy, urea breath test will be performed. If the result of UBT is negative, it means successful eradication. If the result is positive, it means eradicaiton failure

    2~3 months

Study Arms (4)

HDDT group

EXPERIMENTAL

high dose PPI induction (oral rabeprazole 20mg qid) for 3 days, then 14 days combined with amoxicillin (regular dose, daily 2 g, 500mg qid) for high frequency dual therapy.

Drug: Rabeprazole

CATT group

PLACEBO COMPARATOR

conventional triple therapy 14 days (rabeprazole 20 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid)

Drug: Rabeprazole

LHDT group

EXPERIMENTAL

high dose PPI (oral rabeprazole 20mg qid) induction for 3 days, then Rabeprazole 20 mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd for 14 days.

Drug: Rabeprazole

LATT group

PLACEBO COMPARATOR

levofloxacin base rescue therapy 14 days (rabeprazole 20 mg bid, amoxicillin 1 g bid, levofloxacin 500 mg qd)

Drug: Rabeprazole

Interventions

RabeprazoleDRUG

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

Also known as: Amoxicillin
CATT groupHDDT groupLATT groupLHDT group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The source of subjects may include (1) community participants who obtain a positive result of urea breath test (UBT) from the checkup screening (2) hospital patients who obtain a positive result of H. pylori infection by esophagogastroduodenoscopy (EGD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang-Gung memorial hospital at Keelung

Keelung, 20401, Taiwan

Location

MeSH Terms

Interventions

RabeprazoleAmoxicillin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmides

Study Officials

  • Ming-Jui Hung, PhD

    Chang-Gung Memorial Hospital at Keelung

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief, division of hepato-gastroenterology

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 14, 2019

Study Start

January 2, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

TW(1)