NCT02557932

Brief Summary

In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
352

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2015

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 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2019

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

3.3 years

First QC Date

September 21, 2015

Last Update Submit

April 7, 2020

Conditions

Helicobacter Pylori InfectionFamily History of Stomach Cancer

Keywords

PPI standard triple therapyBismuth quadruple therapyHelicobacter

Outcome Measures

Primary Outcomes (1)

  • H. pylori eradication rate

    8 weeks after H. pylori treatment

Secondary Outcomes (5)

  • Complications of H. pylori treatment

    1 month after H. pylori treatment

  • Compliance to H. pylori treatment

    1 month

  • H. pylori infection status at 1 year after H. pylori treatment

    1 year after H. pylori treatment

  • H. pylori reinfection rate

    3 years after success of H. pylori eradication

  • Factors associated with H. pylori reinfection

    3 years after success of H. pylori treatment

Study Arms (2)

Standard triple therapy

ACTIVE COMPARATOR

7 day-PPI based standard triple therapy

Drug: Standard triple therapy

Bismuth quadruple therapy

ACTIVE COMPARATOR

10 day-bismuth quadruple therapy

Drug: Bismuth quadruple therapy

Interventions

Standard triple therapyDRUG

Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days

Also known as: 7-day PPI-based standard triple therapy
Standard triple therapy
Bismuth quadruple therapyDRUG

Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days

Also known as: 10-day Bismuth quadruple therapy
Bismuth quadruple therapy

Eligibility Criteria

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

You may qualify if:

  • Men and women aged 18 or more including following conditions
  • Family history of gastric cancer
  • Post endoscopic resection status for early gastric cancer or adenoma
  • Peptic ulcer disease (benign gastric ulcer and duodenal ulcer)
  • Chronic gastritis
  • Non-ulcer dyspepsia
  • Healthy adults who want to receive H. pylori treatment
  • H. pylori positive by urea breath test, histology, or rapid urease test

You may not qualify if:

  • History of H. pylori eradication therapy
  • History of stomach operation
  • Other organ cancer within 5 years
  • Liver cirrhosis or Hepatic insufficiency
  • Renal insufficiency
  • Current treatment for serious medical condition which may hinder participation
  • Contraindication or allergy history for H. pylori treatment regimens
  • Mental incompetence to understand and sign informed consent
  • Incompatible conditions to be included into the trial by investigators' decision
  • Inability to provide an informed consent
  • History of treatment for peptic ulcer disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Related Publications (1)

  • Kim YI, Lee JY, Kim CG, Park B, Park JY, Choi IJ. Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial. BMC Gastroenterol. 2021 Mar 2;21(1):95. doi: 10.1186/s12876-021-01680-1.

    PMID: 33653284DERIVED

Study Officials

  • Il Ju Choi, M.D., Ph.D.

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of gastroenterology, Center for Gastric Cancer

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 23, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2018

Study Completion

September 28, 2019

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

KR(1)