H Pylori Eradication
Conditions
Brief summary
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
Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.
Interventions
DRUGDexlansoprazole 60 mg once daily
Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm
Sponsors
Ramathibodi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 year-patient 2. Diagnosed as positive Helicobacter Pylori testing by any of the following methods: * Rapid urease test or Histology 3. Inform consent
Exclusion criteria
1. Previous history of Helicobacter pylori eradication 2. Contraindications or allergic reactions to the study drugs 3. Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases 4. Decompensated Liver cirrhosis or chronic kidney disease (GFR\< 30) 5. Mental disorders or alcohol or drug addiction 6. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate (percentage) | Jan17-Nov17, Total 11 months | Compare eradication rate of helicobacter pylori between 2 groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare drug compliance | jan17-Nov17, Total 11 months | The investigators measure drug compliance between 2 groups, The investigators consider more than 85% of taking medications is a good compliance. |
| To compare drug adverse event | jan17-Nov17, Total 11 months | The investigators measure adverse events as 1. Nausea/Vomiting 2. Abdominal pain/Abdominal discomfort/Abdominal Bloating 3. Diarrhea/ Constipation 4. Taste distortions 5. Headache/Dizziness 6. Rash/Itching/Drug allergy, Any symptoms occur new onset during taking medications, The investigators consider as an adverse events of an experiment. |
Countries
Thailand
Outcome results
None listed