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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole 30mg | Drug | lansoprazole 30 mg tablet |
|
| 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. |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Hyun Kim | Inje University Busan Paik hosipital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik hosipital | Busan | South Korea |
There is no plan to make individual patient data available to other researchers.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 2, 2025 | |
| Reset | May 19, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 2, 2025 | May 19, 2025 |
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D000658 | Amoxicillin |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Amoxicillin 1.0g Tab | Drug | Amoxicillin 1.0g tablet |
|
|
| Clarithromycin 500mg | Drug | Clarithromycin 500mg tablet |
|
|
| Metronidazole 500 mg | Drug | Metronidazole 500 mg tablet |
|
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |