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Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PAMB treatment (modified quadruple therapy)
PBMT treatment (bismuth-containing quadruple therapy)
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring helicobacter pylori infection, Drug Resistance, Microbial

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination.
  • Participants who voluntarily want to participate in this study.

Exclusion Criteria:

  • Participants who had history of Helicobacter pylori eradication.
  • Participants who had experience of stomach resection.
  • Participants who had history of allergy or adverse events related to eradication medication.
  • Participants who had history of administration of proton-pump inhibitor within 2 weeks or Histamine 2 receptor blocker within 1 week.
  • Participants who had history of administration of these drugs within a week or who need continuous administration of these drugs; aspirin (except low-dose aspirin for primary prophylaxis of cardiovascular disease), intravenous or oral NSAID, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate
  • Participants who had history of administration of antibiotics within 4 weeks.
  • Pregnant, breast feeding participant or who do not have a will to avoid pregnancy during clinical trial
  • Participants who are administrating one of these drugs (Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergotamine, Dihydroergotamine, Mizolastine, Bepridil, Ticagrelor)
  • Participants who have infectious mononucleosis, central nervous system infection, hematologic disease, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, Torsades de pointes.

Sites / Locations

  • Chuncheon Sacred Heart hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PAMB group

PMBT group

Arm Description

PAMB treatment (modified quadruple therapy) for 14 days

PBMT treatment (bismuth-containing quadruple therapy) for 14 days

Outcomes

Primary Outcome Measures

Rate of eradication success
Eradication success means negative urea breath test done at least after 4 weeks from medication administration

Secondary Outcome Measures

Rate of adverse events related to eradication medication
Adverse events related to eradication medication
Rate of compliance of eradication medication administration
Compliance (percentage of amount) of eradication medication administration

Full Information

First Posted
June 25, 2018
Last Updated
May 21, 2020
Sponsor
Chuncheon Sacred Heart Hospital
Collaborators
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03665428
Brief Title
Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea
Official Title
Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea; Open-label, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chuncheon Sacred Heart Hospital
Collaborators
Hallym University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.
Detailed Description
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, this study did not explore the antibiotic resistance profile of Helicobacter pylori. And, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
helicobacter pylori infection, Drug Resistance, Microbial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
PAMB group (modified quadruple therapy) vs. PBMT group (bismuth-containing quadruple therapy)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAMB group
Arm Type
Experimental
Arm Description
PAMB treatment (modified quadruple therapy) for 14 days
Arm Title
PMBT group
Arm Type
Active Comparator
Arm Description
PBMT treatment (bismuth-containing quadruple therapy) for 14 days
Intervention Type
Drug
Intervention Name(s)
PAMB treatment (modified quadruple therapy)
Other Intervention Name(s)
PBMT treatment (bismuth-containing quadruple therapy)
Intervention Description
Randomly assign either as PAMB or PBMT group treatment
Intervention Type
Drug
Intervention Name(s)
PBMT treatment (bismuth-containing quadruple therapy)
Other Intervention Name(s)
PAMB treatment (modified quadruple therapy)
Intervention Description
Randomly assign either as PAMB or PBMT group treatment
Primary Outcome Measure Information:
Title
Rate of eradication success
Description
Eradication success means negative urea breath test done at least after 4 weeks from medication administration
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Rate of adverse events related to eradication medication
Description
Adverse events related to eradication medication
Time Frame
up to 4 weeks
Title
Rate of compliance of eradication medication administration
Description
Compliance (percentage of amount) of eradication medication administration
Time Frame
up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination. Participants who voluntarily want to participate in this study. Exclusion Criteria: Participants who had history of Helicobacter pylori eradication. Participants who had experience of stomach resection. Participants who had history of allergy or adverse events related to eradication medication. Participants who had history of administration of proton-pump inhibitor within 2 weeks or Histamine 2 receptor blocker within 1 week. Participants who had history of administration of these drugs within a week or who need continuous administration of these drugs; aspirin (except low-dose aspirin for primary prophylaxis of cardiovascular disease), intravenous or oral NSAID, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate Participants who had history of administration of antibiotics within 4 weeks. Pregnant, breast feeding participant or who do not have a will to avoid pregnancy during clinical trial Participants who are administrating one of these drugs (Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergotamine, Dihydroergotamine, Mizolastine, Bepridil, Ticagrelor) Participants who have infectious mononucleosis, central nervous system infection, hematologic disease, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, Torsades de pointes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Seok Bang, MD, PhD
Organizational Affiliation
Hallym University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chuncheon Sacred Heart hospital
City
Chuncheon
State/Province
Gangwon-do
ZIP/Postal Code
24253
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea

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