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New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.
Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once daily dose dexlansoprazole | Experimental | Group 1 Dexlansoprazole 60 mg by oral once daily for 14 days (Levofloxacin 500 mg by oral once daily for 14 days Amoxicillin 1000 mg by oral bid for 14 days Bismuth 1048 mg by oral bid for 14 days) |
|
| Twice daily dose dexlansoprazole | Active Comparator | Group 2 Dexlansoprazole 60 mg oral bid 14 Days (Levofloxacin 500 mg od oral 14 Days Amoxicillin 1000 mg bid oral 14 Days Bismuth 1048 mg bid oral 14 Days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole 60 mg once daily | Drug | Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate (percentage) | Compare eradication rate of helicobacter pylori between 2 groups | Jan17-Nov17, Total 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare drug compliance | The investigators measure drug compliance between 2 groups, The investigators consider more than 85% of taking medications is a good compliance. | jan17-Nov17, Total 11 months |
| To compare drug adverse event |
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Inclusion Criteria:
Age 18-75 year-patient
Diagnosed as positive Helicobacter Pylori testing by any of the following methods:
Inform consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akrawit Pulsombat, Doctor | Ramathibodi Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parin siriwat | Bangkok | 10400 | Thailand |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 3, 2018 | |
| Reset | Nov 2, 2018 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2018 | Apr 2, 2018 | Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 3, 2018 | Nov 2, 2018 |
| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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|
The investigators measure adverse events as
| jan17-Nov17, Total 11 months |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |