Back to resultsEffectiveness 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
Primary Purpose
Helicobacter Pylori Infection
Status
Unknown status
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
13C Urea Breath Test
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter Pylori infection, Non-ulcer Dyspepsia, Rabeprazole-Levofloxacin
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:
- 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.
Sites / Locations
- Thammasat University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rabeprazole-levofloxacin based quadruple therapy for 7 days
Rabeprazole-levofloxacin based quadruple therapy for14 days
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03397680
Brief 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
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Anticipated)
Study Completion Date
May 15, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter Pylori infection, Non-ulcer Dyspepsia, Rabeprazole-Levofloxacin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rabeprazole-levofloxacin based quadruple therapy for 7 days
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rabeprazole-levofloxacin based quadruple therapy for14 days
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
13C Urea Breath Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
6 weeks
Title
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
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
To measure the adverse effect reaction of once-daily regimen of high dose rabeprazole-levofloxacin based quadruple therapy
Description
To measure the adverse effect reaction up to 1 month after randomization
Time Frame
up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ratha-korn Vilaichone
Organizational Affiliation
Gastroenterology Unit, Department of Medicine, Thammasat University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thammasat University Hospital
City
Khlong Luang
State/Province
Patumthanee
ZIP/Postal Code
12121
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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