Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication

April 7, 2020 updated by: Il Ju Choi, National Cancer Center, Korea

Comparison of 7-day Proton Pump Inhibitor (PPI)-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen: Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard triple therapy
7 day-PPI based standard triple therapy
Drug: Standard triple therapy
Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days
Other Names:
  • 7-day PPI-based standard triple therapy
Active Comparator: Bismuth quadruple therapy
10 day-bismuth quadruple therapy
Drug: Bismuth quadruple therapy
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
Other Names:
  • 10-day Bismuth quadruple therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
H. pylori eradication rate
Time Frame: 8 weeks after H. pylori treatment
8 weeks after H. pylori treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications of H. pylori treatment
Time Frame: 1 month after H. pylori treatment
1 month after H. pylori treatment
Compliance to H. pylori treatment
Time Frame: 1 month
1 month
H. pylori infection status at 1 year after H. pylori treatment
Time Frame: 1 year after H. pylori treatment
1 year after H. pylori treatment
H. pylori reinfection rate
Time Frame: 3 years after success of H. pylori eradication
3 years after success of H. pylori eradication
Factors associated with H. pylori reinfection
Time Frame: 3 years after success of H. pylori treatment
3 years after success of H. pylori treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Il Ju Choi, M.D., Ph.D., National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

September 28, 2019

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2015-0207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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