Helicobacter Pylori Eradication Study

NCT03130452 | Completed Phase 4 DMC

• 1 other identifier: 2016-09-0025
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the efficacy and compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy.

  Comparison of percentage of people who succeeded in H. pylori eradication among all participants in each treatment group (tailored therapy vs concomitant therapy)

  At 4 weeks after the completion of drug administration, the urea breath test is performed to check for eradication, Before the urea breath test, the proton pump inhibitor or H2 blocker should be discontinued for 2 weeks.

Secondary Outcomes (1)

• Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin

  Before the treatment, 23S ribosomal RNA point mutation is confirmed and at least 4 weeks after the end of treatment, urea breath test is performed to check whether or not eradication is completed.

Other Outcomes (1)

• Number of remaining medicines of tailored therapy compared to concomitant therapy

  At 4 weeks after the completion of drug administration, when the patient visited for the urea breath test, check the number of remaining medicines.

Study Arms (3)

concomitant group

ACTIVE COMPARATOR

lansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation.

Drug: Lansoprazole 30mg; Drug: Amoxicillin 1.0g Tab; Drug: Clarithromycin 500mg; Drug: Metronidazole 500 mg

tailored treatment group I

EXPERIMENTAL

23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks.

Drug: Lansoprazole 30mg; Drug: Amoxicillin 1.0g Tab; Drug: Clarithromycin 500mg

tailored treatment group II

EXPERIMENTAL

23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks.

Drug: Lansoprazole 30mg; Drug: Clarithromycin 500mg; Drug: Metronidazole 500 mg

Interventions

Lansoprazole 30mg DRUG

lansoprazole 30 mg tablet

Also known as: langton

concomitant group; tailored treatment group I; tailored treatment group II

Amoxicillin 1.0g Tab DRUG

Amoxicillin 1.0g tablet

Also known as: amoxiclav

concomitant group; tailored treatment group I

Clarithromycin 500mg DRUG

Clarithromycin 500mg tablet

Also known as: clavacin

concomitant group; tailored treatment group I; tailored treatment group II

Metronidazole 500 mg DRUG

Metronidazole 500 mg tablet

Also known as: lysinyl

concomitant group; tailored treatment group II

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• H. pylori infection diagnosed patient, between 18 years old and 80 years old
• No history of H. pylori eradication therapy
• No antibiotic use for more than 3 days within 1 month of treatment

You may not qualify if:

• History of taking antibiotics for more than 3 days in the last 1 month
• History of subtotal or partial gastrectomy
• Patients with other systemic disorders such as severe liver function, kidney function, cardiopulmonary function abnormality
• Pregnant and lactating women
• Disagree with the survey or do not respond to the questionnaire
• Contraindications for each medications

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Inje University Busan Paik hosipital

Busan, South Korea

Location

MeSH Terms

Interventions

Lansoprazole; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clarithromycin; Metronidazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Clavulanic Acid; Clavulanic Acids; Drug Combinations; Pharmaceutical Preparations; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Ji Hyun Kim

  Inje University Busan Paik hosipital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 26, 2017
• Study Start: December 17, 2016
• Primary Completion: January 28, 2019
• Study Completion: May 31, 2019
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)