Clinical trial NCT03397680: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori infection
Non-ulcer Dyspepsia
Rabeprazole-Levofloxacin
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with positive rapid urease test or pathologic findings were divided into 2 groups and enrolled into randomization with 1:1 block of four methods. Each participant in group1 received 7-day once daily dose regimen of 1-tablet 750-mg Levofloxacin after meal, 2-tablet 500-mg Clarithromycin MR after meal, 3-tablet 20-mg Rabeprazole before meal and 1-tablet 1,048-mg Gastro bismol after meal.

Meanwhile, each participant in group2 received 14-day once daily dose regimen of 1-tablet 750-mg Levofloxacin after meal, 2-tablet 500-mg Clarithromycin MR after meal, 3-tablet 20-mg Rabeprazole before meal and 1-tablet 1,048-mg Gastro bismol after meal.
Primary purpose: TREATMENT

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 patients with dyspepsia and H.pylori eradication recommended the 14-day triple therapy regimen which had curable about 70% by using proton pump inhibitor (PPI) combined with antibiotics including amoxicillin, clarithromycin and metronidazole.

Up to date, there has been no evidence about the cure rate for H.pylori eradication with once-daily dose regimen of high dose rabeprazole and levofloxacin based therapy. This research is to study the 7-day and 14-day cure rate of H.pylori eradication treatment with once-daily regimen of high dose rabeprazole-levofloxacin based quadruple therapy.


Eligibility criteria: 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:

1. Any cases with upper gastrointestinal bleeding
2. 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.
3. Contraindicated for gastric biopsy such as coagulopathy.
4. Any history of drug allergy for levofloxacin, clarithromycin or rabeprazole.
5. Receiving proton pump inhibitor within 4 weeks or receiving any antibiotics or bismuth within 2 weeks.
6. Being pregnant or raising children with lactation.
7. Having history of H.pylori eradication treatment.
8. 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.
9. Any cases who receiving anticoagulant.
10. Having previous gastric surgery.
11. Unwilling to participate into research.
12. Having history of taking previous medications which interacted with the research treatment.
13. Having underlying heart disease including congenital long QT syndrome.

Primary outcomes:
measure: To measure eradication rate of participants with once-daily dose regimen of 14-day rabeprazole-levofloxacin based quadruple therapy for H. pylori eradication by Urea Breath Test in Thai patients with non-ulcer dyspepsia
timeFrame: 6 weeks
measure: To measure eradication rate of participants with once-daily dose regimen of 7-day rabeprazole-levofloxacin based quadruple therapy for H. pylori eradication by Urea Breath Test in Thai patients with non-ulcer dyspepsia
timeFrame: 5 weeks
Secondary outcomes:
measure: To measure the adverse effect reaction of once-daily regimen of high dose rabeprazole-levofloxacin based quadruple therapy
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University Hospital
state: Patumthanee
Study officials:
affiliation: Gastroenterology Unit, Department of Medicine, Thammasat University Hospital
name: Ratha-korn Vilaichone
role: PRINCIPAL_INVESTIGATOR
References: