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This study compared efficacy and safety of basic triple therapy according to treatment period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy
This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori according to treatment period.
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the UBT test. For 7 days or 10 days Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test at 49±5days from the first day dosing. The investigators would point out the impact of CYP2C19 genotypes on Clarythromycin-based first-line and rescue therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7 days treament group | 7 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D) |
| |
| 10 days treatment group | 10 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment period | Procedure | 7 days treatment or 10 days treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy | The eradication rate of H.pylori after 7 days(or 10 days) treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy or UBT test. The treatment : Noltec(Ilaprazole) 10mg+Pamoxine Cap(Amoxicillin) 1000mg+Clafaxine(Clarithromycin) 500mg was administered twice a day for 7days(or 10days) | Day 49±5(or Day 52±5) |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5(or Day 52±5). Record the number of patients with adverse Events. | Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such. | Day 49±5(or Day 52±5) |
| The eradication rate of H.pylori according to CYP polymorphism of patients. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who visited the hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongsoo Lee | Contact | endoscope@hanmail.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic Univ. of Korea Daejeon St.Mary Hospital | Recruiting | Daejeon | South Korea |
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Blood to anlysis of CYP polymorphism
The eradication rate of H.pylori is analyzed accroding to CYP polymorphism: CYP2C19 homo EM, hetero EM, PM |
| Day 49±5(or Day 52±5) |
| The eradication rate of H.pylori according to stage of disease of patients. | The eradication rate of H.pylori is analyzed accroding to stage of disease: active stage, healing stage, scar stage, gastritis. | Day 49±5(or Day 52±5) |
| The Chunngnam Univ. General Hospital | Not yet recruiting | Daejeon | South Korea |
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| The Eulji Univ. General Hospital | Not yet recruiting | Daejeon | South Korea |
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| The Konyang Univ. General Hospital | Not yet recruiting | Daejeon | South Korea |
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