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

NCT03397680 | Unknown Phase 1 DMC

• 1 other identifier: MTU-EC-IM-2-200/59
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori infection; Non-ulcer Dyspepsia; Rabeprazole-Levofloxacin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• To measure the adverse effect reaction of once-daily regimen of high dose rabeprazole-levofloxacin based quadruple therapy

  up to 1 month

Study Arms (2)

Rabeprazole-levofloxacin based quadruple therapy for 7 days

ACTIVE COMPARATOR

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

Rabeprazole-levofloxacin based quadruple therapy for14 days

ACTIVE COMPARATOR

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

Interventions

13C Urea Breath Test DIAGNOSTIC_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 for 7 days; Rabeprazole-levofloxacin based quadruple therapy for14 days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University Hospital

Khlong Luang, Patumthanee, 12121, Thailand

Location

Study Officials

• Ratha-korn Vilaichone

  Gastroenterology Unit, Department of Medicine, Thammasat University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2017
• First Posted: January 12, 2018
• Study Start: May 15, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

TH (1)