Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

Study Overview
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Brief Summary
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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.

Detailed Description
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Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.

Official Title
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Once Daily Dose Dexlansoprazole Levofloxacin Based Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Controlled Study

Conditions
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H Pylori Eradication

Intervention / Treatment
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* Drug: Dexlansoprazole 60 mg once daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 year-patient Diagnosed as positive Helicobacter Pylori testing by any of the following methods: Rapid urease test or Histology Inform consent Exclusion Criteria: Previous history of Helicobacter pylori eradication Contraindications or allergic reactions to the study drugs Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases Decompensated Liver cirrhosis or chronic kidney disease (GFR< 30) Mental disorders or alcohol or drug addiction Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once daily dose dexlansoprazole<br>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) | Drug: Dexlansoprazole 60 mg once daily<br>* Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm<br>* Other names: dexilant;|
| Active Comparator: Twice daily dose dexlansoprazole<br>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) | Drug: Dexlansoprazole 60 mg once daily<br>* Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm<br>* Other names: dexilant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate (percentage) | Compare eradication rate of helicobacter pylori between 2 groups | Jan17-Nov17, Total 11 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | The investigators measure adverse events as Nausea/Vomiting Abdominal pain/Abdominal discomfort/Abdominal Bloating Diarrhea/ Constipation Taste distortions Headache/Dizziness Rash/Itching/Drug allergy, Any symptoms occur new onset during taking medications, The investigators consider as an adverse events of an experiment. | jan17-Nov17, Total 11 months |