High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment

November 2, 2018 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Efficacy of High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment：a Randomized Clinical Trial

Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori treatment.This study is designed to evaluate the efficacy and safety of the addition of bismuth to high dose of dual therapy for H. pylori eradication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 18 years old
  • With previous gastric surgery
  • Major systemic diseases
  • Pregnancy or lactation
  • Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bismuth Plus Dual Therapy
Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Bismuth Potassium Citrate 600mg bid for 14 days.
Drug: Esomeprazole
Proton pump inhibitor
Drug: Amoxicillin
Antibiotic for H. pylori eradication
Drug: Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
ACTIVE_COMPARATOR: Dual Therapy
Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days.
Drug: Esomeprazole
Proton pump inhibitor
Drug: Amoxicillin
Antibiotic for H. pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helicobacter pylori eradication rate
Time Frame: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
Six weeks after completion of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse effects
Time Frame: Within 7 days after completion of therapy.
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).
Within 7 days after completion of therapy.
Compliance rate
Time Frame: Within 7 days after completion of therapy.
Compliance was defined as poor when they had taken less than 80% of the total medication.
Within 7 days after completion of therapy.

Collaborators and Investigators

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

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Hong Lu, M.D, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

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)

January 3, 2018

Primary Completion (ACTUAL)

November 2, 2018

Study Completion (ACTUAL)

November 2, 2018

Study Registration Dates

First Submitted

January 13, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (ACTUAL)

January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjkls2017196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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