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

NCT03665428 | Completed Phase 4

• 1 other identifier: CSBang2018HP
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

helicobacter pylori infection; Drug Resistance, Microbial

Outcome Measures

Primary Outcomes (1)

• Rate of eradication success

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

  up to 4 weeks

Secondary Outcomes (2)

• Rate of adverse events related to eradication medication

  up to 4 weeks

• Rate of compliance of eradication medication administration

  up to 4 weeks

Study Arms (2)

PAMB group

EXPERIMENTAL

PAMB treatment (modified quadruple therapy) for 14 days

Drug: PAMB treatment (modified quadruple therapy)

PMBT group

ACTIVE COMPARATOR

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

Drug: PBMT treatment (bismuth-containing quadruple therapy)

Interventions

PAMB treatment (modified quadruple therapy) DRUG

Randomly assign either as PAMB or PBMT group treatment

Also known as: PBMT treatment (bismuth-containing quadruple therapy)

PAMB group

PBMT treatment (bismuth-containing quadruple therapy) DRUG

Randomly assign either as PAMB or PBMT group treatment

Also known as: PAMB treatment (modified quadruple therapy)

PMBT group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead
• Hallym University Medical Center: collaborator

Study Sites (1)

Chuncheon Sacred Heart hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

Study Officials

• Chang Seok Bang, MD, PhD

  Hallym University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Hallym University College of Medicine

Model Details: PAMB group (modified quadruple therapy) vs. PBMT group (bismuth-containing quadruple therapy)

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: September 11, 2018
• Study Start: July 16, 2018
• Primary Completion: August 6, 2019
• Study Completion: December 31, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)