Clinical trial NCT01566643: Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections
Official title: Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
antibiotic resistance
sequential-concomitant hybrid therapy
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University
First posted: 2012-03-29
Enrollment: 231
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective controlled randomized open-label clinical trial is designed to determine the optimal eradication rate of rabeprazole based sequential-concommitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan. Enrolled patients will receive 3, 5 or 7 days of pre-concommitant (sequential part) treatment with rabeprazole + amoxicillin, then 7 days of concommitant treatment with rabeprazole + amoxicillin + clarithromycin + metronidazole.

Detailed description: Background: Antimicrobial resistance has decreased the worldwide eradication rates of common used triple therapy for Helicobacter pylori infection (less than 80%).

Objective: To determine the optimal pre-concommitant treatment length for rabeprazole based sequential-concomitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan.

Design: Randomized, open-label, prospective controlled trial.

Patients: 231 patients with dyspepsia or peptic ulcers and infected by Helicobacter pylori.

Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.

Intervention: 231 patients with Helicobacter pylori infection are recruited and randomly assigned to receive one of the following therapeutic schemes: group 1, 14-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 7 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days; group 2, 12-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 5 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days; group 3, 10-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 3 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days. Repeat upper endoscopy for histologic evaluation, rapid urease test or 13C-urea breath test after 4 week of treatment to assess the treatment result. The influence on the hybrid therapies of antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host were determined.

Expected results: The rabeprazole based sequential-concomitant therapies for eradication of Helicobacter pylori is very effective, and the outcome is not affected by antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host.

Eligibility criteria: Inclusion Criteria:

* Patient proved with infection of H. pylori in gastric mucosa (at least two of four tests positive)

Exclusion Criteria:

* woman in breast feeding or pregnancy.
* allergy to drugs used in study.
* previously treated for H. pylori.
* intolerance to fructose, lactose.
* patients with hematologic, brain or spinal disorders
* patients under 20 years old
* patients under aspirin or clopidogrel
* patients with history of gastric cancer or gastric resection operation.

Primary outcomes:
measure: Eradication rate
timeFrame: 4 weeks after complete use of drug for treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
Study officials:
affiliation: Buddhist Tzu Chi General Hospital
name: Ming-Cheh CHEN, MD
role: PRINCIPAL_INVESTIGATOR
References: