NCT03321773

Brief Summary

Reverse hybrid therapy achieves a higher eradication rate than bismuth (triple therapy plus bismuth) 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 2017

Longer than P75 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, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
3.1 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

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

3.9 years

First QC Date

October 20, 2017

Last Update Submit

March 12, 2019

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)

triple therapy plus bismuth therapy

EXPERIMENTAL

pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.

Drug: triple therapy plus bismuth therapy

reverse hybrid therapy

ACTIVE COMPARATOR

(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)

Drug: reverse hybrid therapy

Interventions

triple therapy plus bismuth therapyDRUG

pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.

Also known as: pantoprazole 40 mg, amoxicillin 1g, clarithromycin 500mg, bismuth subcitrate 240mg
triple therapy plus bismuth therapy
reverse hybrid therapyDRUG

(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)

Also known as: pantoprazole 40mg, amoxicillin 1g, clarithromycin 500mg, metronidazole 500mg
reverse hybrid 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

RECRUITING

MeSH Terms

Interventions

PantoprazoleAmoxicillinClarithromycinbismuth tripotassium dicitrateMetronidazole

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.

    STUDY CHAIR

Central Study Contacts

Feng-Woei Tsay, Bachelor

CONTACT

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

Ping-I Hsu, Bachelor

CONTACT

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

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
Assistant Professor

Study Record Dates

First Submitted

October 20, 2017

First Posted

October 26, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

TW(1)