Status:
UNKNOWN
Effectiveness of Once-daily Dose Regimen of 7-day and 14-day High Dose Rabeprazole-levofloxacin Based Quadruple Therapy for H. Pylori Eradication in Thai Patients With Non-ulcer Dyspepsia
Lead Sponsor:
Thammasat University
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
H.pylori is an organism which causes gastric inflammation, peptic ulcer disease (PUD), mucosa associated lymphoid tissue (MALT) lymphoma and gastric cancer. Practical guideline for treatment of patie...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Thai patients with the age between 18 and 70 years
- Detecting for H.pylori infection with positive urease test and/or pathological findings of H.pylori and/or positive
- Exclusion criteria:
- Any cases with upper gastrointestinal bleeding
- Being treated with medications affecting the research outcome, for example, by using antibiotics including amoxicillin, clarithromycin, metronidazole or fluoroquinolone within 1 month before the enrollment.
- Contraindicated for gastric biopsy such as coagulopathy.
- Any history of drug allergy for levofloxacin, clarithromycin or rabeprazole.
- Receiving proton pump inhibitor within 4 weeks or receiving any antibiotics or bismuth within 2 weeks.
- Being pregnant or raising children with lactation.
- Having history of H.pylori eradication treatment.
- Having severe underlying disease including end-stage renal disease requiring hemodialysis or peritoneal dialysis (GFR \< 15), cirrhosis with Child-Pugh classification grade C, immunocompromised host with AIDS, malignancy and/or bed ridden cerebrovascular disease.
- Any cases who receiving anticoagulant.
- Having previous gastric surgery.
- Unwilling to participate into research.
- Having history of taking previous medications which interacted with the research treatment.
- Having underlying heart disease including congenital long QT syndrome.
Exclusion
Key Trial Info
Start Date :
May 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03397680
Start Date
May 15 2017
End Date
May 15 2018
Last Update
May 1 2018
Active Locations (1)
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1
Thammasat University Hospital
Khlong Luang, Patumthanee, Thailand, 12121