A Phase 4 interventional study of Lansoprazole 30mg and Amoxicillin 1.0g Tab in Helicobacter Pylori Infection, sponsored by Inje University. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Inje University · Phase 4, Interventional, and Treatment
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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.
Purpose of Study>
Patients>
; Target disease
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.
Inje University is the lead sponsor of 93 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
lansoprazole 30 mg tablet
Also known as: langton
Amoxicillin 1.0g tablet
Also known as: amoxiclav
Clarithromycin 500mg tablet
Also known as: clavacin
Metronidazole 500 mg tablet
Also known as: lysinyl
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)
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: At 4 weeks after the completion of drug administration, when the patient visited for the urea breath test, check the number of remaining medicines.
Plan to share: No — There is no plan to make individual patient data available to other researchers.
No publications or documents are linked to this record.
Ran from Dec 2016 to primary completion in Jan 2019, 25 months.
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Inje University