Helicobacter Pylori Eradication Study

Helicobacter Pylori Eradication Rates of Concomitant Therapy and Tailored Therapy Based on 23S Ribosomal RNA Point Mutations Associated With Clarithromycin Resistance: A Multicenter Prospective Randomized Study

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.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Lansoprazole 30mg; Drug: Amoxicillin 1.0g Tab; Drug: Clarithromycin 500mg; Drug: Metronidazole 500 mg

Detailed Description

Purpose of Study>

1. To evaluate the efficacy of tailored therapy compared to concomitant therapy.
2. Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin.
3. To evaluate the compliance of tailored therapy compared to concomitant.
4. To analysis of factors which influence to the eradication rate.

Patients>

; Target disease

• peptic ulcers(gastric ulcer, duodenal ulcer),
• gastric MALToma,
• Endoscopic therapy state of early gastric cancer or gastric adenoma,
• Patients who require H. pylori testing by clinical judgment, such as chronic gastritis.

Method>

Patients with H. pylori infection who have been screened for a 23S ribosomal RNA point mutation (A2142G, A2143G point mutation) and randomized to a concomitant treatment group and a tailored treatment group. In concomitant treatment group, lansoprazole 30 mg, amoxicillin 1.0 g, metronidazole 500 mg and clarithromycin 500 mg were administered twice a day for 2 weeks, regardless of 23S ribosomal RNA point mutation. In tailored treatment group, In the case of 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. In tailored treatment group, In point mutation positive cases, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. For each treatment group, at least 4 weeks after completion of drug administration, confirm the sterilization and confirm the compliance and adverse effects of the drug.

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Busan Paik hosipital

Participation Criteria

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:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: concomitant group; 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; lansoprazole 30 mg tablet; Other Names: langton; Drug: Amoxicillin 1.0g Tab; Amoxicillin 1.0g tablet; Other Names: amoxiclav; Drug: Clarithromycin 500mg; Clarithromycin 500mg tablet; Other Names: clavacin; Drug: Metronidazole 500 mg; Metronidazole 500 mg tablet; Other Names: lysinyl
Experimental: tailored treatment group I; 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; lansoprazole 30 mg tablet; Other Names: langton; Drug: Amoxicillin 1.0g Tab; Amoxicillin 1.0g tablet; Other Names: amoxiclav; Drug: Clarithromycin 500mg; Clarithromycin 500mg tablet; Other Names: clavacin
Experimental: tailored treatment group II; 23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks.	Drug: Lansoprazole 30mg; lansoprazole 30 mg tablet; Other Names: langton; Drug: Clarithromycin 500mg; Clarithromycin 500mg tablet; Other Names: clavacin; Drug: Metronidazole 500 mg; Metronidazole 500 mg tablet; Other Names: lysinyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin	Identify the effect of 23S ribosomal RNA point mutation on the eradication rate regardless of the administration drug.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of remaining medicines of tailored therapy compared to concomitant therapy	After taking the treatment drug, take out all remaining medicine in the outpatient clinic room, check the number of remaining medicines, and judge compliance.	At 4 weeks after the completion of drug administration, when the patient visited for the urea breath test, check the number of remaining medicines.

Collaborators and Investigators

• Sponsor: Inje University
• Investigators: Principal Investigator: Ji Hyun Kim, Inje University Busan Paik hosipital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): February 28, 2018
• Study Completion (Anticipated): May 31, 2018

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Metronidazole; Dexlansoprazole; Lansoprazole; Amoxicillin; Clarithromycin
• Other Study ID Numbers: 2016-09-0025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual patient data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No