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
NCT ID: NCT03397680
Last Updated: 2018-05-01
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
100 participants
INTERVENTIONAL
2017-05-15
2018-05-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori
NCT03087162
Daily Four Times or Two Times Usage of PPI and Amoxicillin for the First or Second Line H. Pylori Eradication
NCT03802318
14-day PCAB-based High-dose Dual Therapy and14-day PCAB-based Triple Therapy vs 14-day PPI-based Reverse Hybrid Therapy
NCT05191888
A Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection
NCT03658733
Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
NCT00197418
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Detecting for H.pylori infection with positive urease test and/or pathological findings of H.pylori and/or positive
Exclusion Criteria
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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Thammasat University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jeerayuth Auttajaroon
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ratha-korn Vilaichone
Role: PRINCIPAL_INVESTIGATOR
Gastroenterology Unit, Department of Medicine, Thammasat University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Thammasat University Hospital
Khlong Luang, Patumthanee, Thailand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MTU-EC-IM-2-200/59
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.