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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03397680
• Other study ID #: MTU-EC-IM-2-200/59
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 15, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: April 2018
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

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.

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital	Khlong Luang	Patumthanee

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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