Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori
NCT ID: NCT03087162
Last Updated: 2018-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
180 participants
INTERVENTIONAL
2017-01-01
2017-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Once daily dose dexlansoprazole
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)
Dexlansoprazole 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
Twice daily dose dexlansoprazole
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)
Dexlansoprazole 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
Interventions
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Dexlansoprazole 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed as positive Helicobacter Pylori testing by any of the following methods:
* Rapid urease test or Histology
3. Inform consent
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Ramathibodi Hospital
OTHER
Responsible Party
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Parin siriwat
Fellowship of Gastroenterology Unit, Ramathibodi Hospital
Principal Investigators
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Akrawit Pulsombat, Doctor
Role: STUDY_DIRECTOR
Ramathibodi Hospital
Locations
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Parin siriwat
Bangkok, , Thailand
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Psiriwat
Identifier Type: -
Identifier Source: org_study_id
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