NCT03779074

Brief Summary

Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
918

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3.3 years

First QC Date

December 16, 2018

Last Update Submit

October 24, 2023

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriEradication rate

Outcome Measures

Primary Outcomes (1)

  • Number of Participants in Which H. Pylori Was Eradicated

    To assess eradication efficacy with urea breath test

    sixth week after the end of anti- H. pylori therapy

Study Arms (3)

10d bismuth quadruple therapy

ACTIVE COMPARATOR

rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days.

Drug: 10d bismuth quadruple therapy

14d hybrid therapy

EXPERIMENTAL

a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days.

Drug: 14d hybrid therapy

14d high-dose dual therapy

EXPERIMENTAL

rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days

Drug: 14D high-dose dual therapy

Interventions

10d bismuth quadruple therapyDRUG

rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days

Also known as: rabeprazole 20 mg bid, tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, metronidazole 250 mg qid
10d bismuth quadruple therapy
14d hybrid therapyDRUG

a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days

Also known as: rabeprazole 20 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, metronidazole 500 mg bid
14d hybrid therapy
14D high-dose dual therapyDRUG

rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days

Also known as: rabeprazole 20 mg qid, amoxicillin 750 mg qid
14d high-dose dual therapy

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

You may not qualify if:

  • previous H pylori-eradication therapy
  • ingestion of antibiotics or bismuth within the prior 4 weeks
  • patients with allergic history to the medications used
  • patients with previous gastric surgery
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (1)

  • Hsu PI, Chen KY, Tai WC, Yang JC, Tsay FW, Liu YH, Chen CL, Lee CL, Yeh HZ, Kuo CH, Chuah SK, Lee HC, Shie CB, Shiu SI, Kao JY, Yamaoka Y, Graham DY, Wu DC; Taiwan Acid-related Disease (TARD) Study Group. Hybrid, High-Dose Dual and Bismuth Quadruple Therapies for First-Line Treatment of Helicobacter pylori Infection in Taiwan: A Multicenter, Open-Label, Randomized Trial. Am J Gastroenterol. 2023 Jul 1;118(7):1184-1195. doi: 10.14309/ajg.0000000000002255. Epub 2023 Mar 20.

    PMID: 36940437DERIVED

MeSH Terms

Interventions

RabeprazoleBID protein, humanTetracyclineMetronidazoleAmoxicillinClarithromycin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesErythromycinMacrolidesPolyketidesLactones

Study Officials

  • Ping-I Hsu, Bachelor

    Kaohsiung Veterans General Hospital.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2018

First Posted

December 19, 2018

Study Start

September 3, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)