NCT04566211

Brief Summary

Reverse hybrid therapy achieves a higher eradication rate than triple therapy plus bismuth therapy remains unanswered.

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
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

September 22, 2020

Last Update Submit

September 22, 2020

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,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

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

Study Arms (2)

(panto+amox+clar+metr)+(panto+amox)

EXPERIMENTAL

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Drug: (panto+amox+clar+metr)+(panto+amox)

pantoprazole+bismuth+amox+clar

ACTIVE COMPARATOR

pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days

Drug: pantoprazole+bismuth+amox+clar

Interventions

(panto+amox+clar+metr)+(panto+amox)DRUG

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Also known as: pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, metronidazole 500 mg
(panto+amox+clar+metr)+(panto+amox)
pantoprazole+bismuth+amox+clarDRUG

pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days

Also known as: pantoprazole 40 mg, bismuth subcitrate 120 mg, amoxicillin 1 g, clarithromycin 500 mg
pantoprazole+bismuth+amox+clar

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

RECRUITING

MeSH Terms

Interventions

PantoprazoleAmoxicillinClarithromycinMetronidazolebismuth tripotassium dicitrate

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Feng-Woei Tsay, Bachelor

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng-Woei Tsay, Bachelor

CONTACT

+886-7-342-2121fwchaie@vghks.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 28, 2020

Study Start

January 1, 2020

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

September 28, 2020

Record last verified: 2020-09

Locations

TW(1)