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

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ClinicalTrials.gov Identifier: NCT03665428
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
Hallym University Medical Center
Information provided by (Responsible Party):
Chang Seok Bang, Chuncheon Sacred Heart Hospital

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: PAMB treatment (modified quadruple therapy) Drug: PBMT treatment (bismuth-containing quadruple therapy) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PAMB group (modified quadruple therapy) vs. PBMT group (bismuth-containing quadruple therapy)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea; Open-label, Randomized Controlled Trial
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : June 6, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: PAMB group
PAMB treatment (modified quadruple therapy) for 14 days
Drug: PAMB treatment (modified quadruple therapy)
Randomly assign either as PAMB or PBMT group treatment
Other Name: PBMT treatment (bismuth-containing quadruple therapy)

Active Comparator: PMBT group
PBMT treatment (bismuth-containing quadruple therapy) for 14 days
Drug: PBMT treatment (bismuth-containing quadruple therapy)
Randomly assign either as PAMB or PBMT group treatment
Other Name: PAMB treatment (modified quadruple therapy)




Primary Outcome Measures :
  1. Rate of eradication success [ Time Frame: up to 4 weeks ]
    Eradication success means negative urea breath test done at least after 4 weeks from medication administration


Secondary Outcome Measures :
  1. Rate of adverse events related to eradication medication [ Time Frame: up to 4 weeks ]
    Adverse events related to eradication medication

  2. Rate of compliance of eradication medication administration [ Time Frame: up to 4 weeks ]
    Compliance (percentage of amount) of eradication medication administration



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665428


Contacts
Contact: Chang Seok Bang, MD, PhD +821052657810 csbang@hallym.ac.kr
Contact: Hyun Lim, MD, PhD +821081512295 hlim77@hallym.or.kr

Locations
Korea, Republic of
Chuncheon Sacred Heart hospital Recruiting
Chuncheon, Gangwon-do, Korea, Republic of, 24253
Contact: Chang Seok Bang, M.D., Ph.D.    +82-33-240-5000    cloudslove@naver.com   
Principal Investigator: Chang Seok Bang, M.D., Ph.D.         
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Hallym University Medical Center
Investigators
Principal Investigator: Chang Seok Bang, MD, PhD Hallym University

Responsible Party: Chang Seok Bang, Associate professor of Hallym University College of Medicine, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03665428     History of Changes
Other Study ID Numbers: CSBang2018HP
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang Seok Bang, Chuncheon Sacred Heart Hospital:
helicobacter pylori infection
Drug Resistance, Microbial

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bismuth
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents