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This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody.
The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| triple with clarithromycin | Experimental | Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks |
|
| triple with metronidazole | Experimental | Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks |
|
| quadruple | Experimental | Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ilaprazole | Drug | Ilaprazole 10mg 1tablet qid(4 times/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate after tailored therapy assessed by urea breath test | After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT. | Test at 4 -6 weeks after completion of medication |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by questionnaire | During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire. | Questionnaire and diary during medication for 14days |
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Inclusion Criteria:
• 20 year old ≤ Male or female < 80 year old
Exclusion Criteria:
Known hypersensitivity to experimental and concomitant drugs
Subjects who are taking contraindicated medications for experimental and concomitant drug.
Subjects with abnormal levels in the laboratory tests
Administrated of PPI, antibiotic medication within 2 weeks prior to commencement of the study.
Pregnant and/or lactating women
Reproductive aged women not using contraception
Uncontrolled diabetics
Uncontrolled hypertension
Uncontrolled liver dysfunction
Alcoholics
Subjects with a history or possibility of digestive malignancy within 5 years
Subjects with a history of gastrectomy or esophagectomy
Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
Subjects participating in a clinical trial before another trial within 30 days
Inconsistence judged subject by researcher
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| Name | Affiliation | Role |
|---|---|---|
| Seong Woo Jeon | Kyungpook national university medical center | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 12, 2020 | |
| Reset | Aug 26, 2020 | |
| Release | Aug 29, 2020 | |
| Reset | Sep 17, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 12, 2020 | Aug 26, 2020 | |||
| Aug 29, 2020 |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C119615 | ilaprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Amoxicillin | Drug | Amoxicillin 500mg 1capsule qid(4times/day) |
|
|
| Clarithromycin | Drug | Clarithromycin 500mg 1tablet bid(2times/day) |
|
|
| Metronidazole | Drug | Metronidazole 250mg 2tablets tid(3times/day) |
|
|
| Sep 17, 2020 |
| D013272 | Stomach Diseases |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |