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

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.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Diagnostic test: 13C Urea Breath Test

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Patumthanee
    • Khlong Luang, Patumthanee, Thailand, 12121
      • Thammasat University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rabeprazole-levofloxacin based quadruple therapy for 7 days; Participant will 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.	Diagnostic test: 13C Urea Breath Test; After the H.pylori eradication treatment course completed, participants then was tested with 13C Urea Breath Test to confirm treatment effectiveness at least after ceasing PPI and antibiotics for 4 weeks.
Active Comparator: Rabeprazole-levofloxacin based quadruple therapy for14 days; Pparticipant will 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	Diagnostic test: 13C Urea Breath Test; After the H.pylori eradication treatment course completed, participants then was tested with 13C Urea Breath Test to confirm treatment effectiveness at least after ceasing PPI and antibiotics for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Participants with positive rapid urease test or pathologic findings evidenced for H.pylori received 14-day once daily dose regimen. After the H.pylori eradication treatment course completed, participants then was tested with 13C Urea Breath Test to confirm the effectiveness of the treatment at 4 weeks. Eradication rate was defined as proportion of post-treatment cases with negative urea breath test compared to pre-treatment cases with positive rapid urease test or pathologic findings evidenced for H.pylori.	6 weeks
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	Participants with positive rapid urease test or pathologic findings evidenced for H.pylori received 7-day once daily dose regimen. After the H.pylori eradication treatment course completed, participants then was tested with 13C Urea Breath Test to confirm the effectiveness of the treatment at 4 weeks. Eradication rate was defined as proportion of post-treatment cases with negative urea breath test compared to pre-treatment cases with positive rapid urease test or pathologic findings evidenced for H.pylori.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the adverse effect reaction of once-daily regimen of high dose rabeprazole-levofloxacin based quadruple therapy	To measure the adverse effect reaction up to 1 month after randomization	up to 1 month

Collaborators and Investigators

• Sponsor: Thammasat University
• Investigators: Principal Investigator: Ratha-korn Vilaichone, Gastroenterology Unit, Department of Medicine, Thammasat University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Anticipated): May 15, 2018
• Study Completion (Anticipated): May 15, 2018

Study Registration Dates

• First Submitted: September 9, 2017
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 28, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Helicobacter Pylori infection; Non-ulcer Dyspepsia; Rabeprazole-Levofloxacin
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: MTU-EC-IM-2-200/59

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No