NCT02732249

Brief Summary

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1.5 years

First QC Date

April 4, 2016

Last Update Submit

June 24, 2018

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriClarithromycinAmoxicillinMetronidazoleEradication

Outcome Measures

Primary Outcomes (1)

  • Helicobacter pylori eradication rate

    Six weeks after completion of therapy

Secondary Outcomes (2)

  • Rate of adverse effects

    within 7 days after completion of therapy

  • Compliance rate

    within 7 days after completion of therapy

Study Arms (3)

Triple regimen group

ACTIVE COMPARATOR

Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days

Drug: EsomeprazoleDrug: ClarithromycinDrug: Metronidazole

Low metronidazole group

EXPERIMENTAL

Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days

Drug: EsomeprazoleDrug: Bismuth Potassium CitrateDrug: ClarithromycinDrug: Metronidazole

High metronidazole group

EXPERIMENTAL

Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days

Drug: EsomeprazoleDrug: Bismuth Potassium CitrateDrug: ClarithromycinDrug: Metronidazole

Interventions

EsomeprazoleDRUG

Given 30 min before morning and evening meals

High metronidazole groupLow metronidazole groupTriple regimen group
Bismuth Potassium CitrateDRUG

Given 30 min before morning and evening meals

High metronidazole groupLow metronidazole group
ClarithromycinDRUG

Given 30 min after morning and evening meals

High metronidazole groupLow metronidazole groupTriple regimen group
MetronidazoleDRUG

Given 30 min after meals or at bedtime

High metronidazole groupLow metronidazole groupTriple regimen group

Eligibility Criteria

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

You may qualify if:

  • Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
  • Ability and willingness to participate in the study and to sign and give informed consent
  • confirmed H. pylori infection

You may not qualify if:

  • Previous H. pylori eradication therapy
  • Less than 18 years old
  • With history of H. pylori infection treatment
  • With previous gastric surgery
  • Major systemic diseases
  • Pregnancy or lactation
  • Allergy to any of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Interventions

EsomeprazoleClarithromycinMetronidazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingErythromycinMacrolidesPolyketidesLactonesNitroimidazolesNitro CompoundsImidazolesAzoles

Study Officials

  • Hong lu, MD

    Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

April 1, 2016

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)