NCT05152004

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. This study aims to better understand the potential of both hybrid and igh-dose dual therapies 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
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

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 1, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

July 20, 2022

Status Verified

December 1, 2021

Enrollment Period

3.2 years

First QC Date

November 28, 2021

Last Update Submit

July 19, 2022

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori eradicationHybrid therapyHigh dose dual proton pump inhibitor and Amoxicillin therapy

Outcome Measures

Primary Outcomes (1)

  • The rates of H.pylori eradication

    The primary outcome variables were the rates of eradication. Chi-square test with or without Yates correction for continuity and Fisher's exact test were used when appropriate to compare the major outcomes between groups. A P value less than 0.05 was considered statistically significant.

    4-8 weeks

Study Arms (2)

High dose dual therapy

EXPERIMENTAL

Rabeprazole (Pariet) 20 mg and amoxicillin (Amolin) 750 mg q.i.d for 14 days

Drug: ParietDrug: Amolin

Hybrid therapy

ACTIVE COMPARATOR

Rabeprazole (Pariet) 20 mg and amoxicillin (Amolin) 1 g b.i.d. for 7 days, followed by rabeprazole (Pariet) 20 mg, amoxicillin(Amolin)1 g, clarithromycin (Klaricid) 500 mg, and metronidazole (Flagyl) 500 mg b.i.d. for 7 days

Drug: ParietDrug: AmolinDrug: KlaricidDrug: Flagyl

Interventions

ParietDRUG

Rabeprazole 20 mg and amoxicillin 750 mg qid for 14 days

Also known as: Rabeprazole
High dose dual therapyHybrid therapy
AmolinDRUG

Rabeprazole 20 mg and amoxicillin 750 mg qid for 14 days

Also known as: Amoxicillin
High dose dual therapyHybrid therapy
KlaricidDRUG

Rabeprazole 20 mg and amoxicillin 1 g bid. for 7 days, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg bid. for 7 days

Also known as: Clarithromycin
Hybrid therapy
FlagylDRUG

Rabeprazole 20 mg and amoxicillin 1 g bid. for 7 days, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg bid. for 7 days

Also known as: Metronidazole
Hybrid therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. H. pylori-infected outpatients with endoscopically proven peptic ulcer diseases or gastritis.

You may not qualify if:

  • Previous H. pylori-eradication therapy
  • ingestion of antibiotics, bismuth, or PPIs 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)

Chang Gung Memorial Hospital

Kaohsiung City, 83300, Taiwan

Location

Related Publications (1)

  • Tai WC, Yang SC, Yao CC, Wu CK, Liu AC, Lee CH, Kuo YH, Chuah SK, Liang CM. The Efficacy and Safety of 14-day Rabeprazole Plus Amoxicillin High Dose Dual Therapy by Comparing to 14-day Rabeprazole-Containing Hybrid Therapy for the Naive Helicobacter pylori Infection in Taiwan: A Randomized Controlled Trial. Infect Dis Ther. 2023 May;12(5):1415-1427. doi: 10.1007/s40121-023-00811-3. Epub 2023 May 3.

    PMID: 37133673DERIVED

MeSH Terms

Interventions

RabeprazoleAmoxicillinClarithromycinMetronidazole

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Wei-Chen Tai, MD

    Kaohsiung Chang Gung Memorial Hospital,Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional Study Model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 28, 2021

First Posted

December 9, 2021

Study Start

September 1, 2018

Primary Completion

November 30, 2021

Study Completion

February 28, 2022

Last Updated

July 20, 2022

Record last verified: 2021-12

Locations

TW(1)