NCT01513785

New Dual Therapy for Primary Treatment of Helicobacter Pylori Infection：a Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The efficacy of traditional triple therapy has been decreased to such an unacceptable level as 70% in many areas. The study is based on the hypothesis: the most important factors which influence the effect of Helicobacter pylori (H. pylori) eradication included acid suppression intensity and sensitivity of antibiotics. So the investigators chose dual therapy because it is simple and verified to be useful. Rabeprazole, as a new proton pump inhibitor (PPI), is reported to be less susceptible to the influence of genetic polymorphisms for CYP2C19. So it has a greater and faster acid suppression effect compared to other PPIs. Amoxicillin is one of effective antibiotics to H. pylori with few side effects. The antibiotic resistance of Amoxicillin is no more than 3% in China. The purpose of our trial is to evaluate and compare the efficacy and safety of dual therapy regimens with different doses of Rabeprazole for initial treatment of H. pylori infection.

Detailed description

The current recommended triple regimen for H. pylori treatment provides unacceptable low success rates because of high antibiotic resistance and poor compliance. Dual therapy had been used before and can be modified to get good eradication rate. The aim of our trial is to evaluate and compare the efficacy and safety of dual therapy regimens for initial treatment of H. pylori infection. A total of forty patients with non-ulcer dyspepsia and H. pylori infection were randomized to receive either Rabeprazole 10 mg b.i.d. and Amoxicillin 1000 mg t.i.d., for 14 days (R10A), or high-dose Rabeprazole 20 mg twice a day (b.i.d.) and Amoxicillin 1000 mg three times a day (t.i.d) (R20A) for 14 days. H. pylori strains were isolated and antibiotic resistance was measured by the twofold agar dilution method. H. pylori eradication was assessed by 13C-urea breath test at 4 weeks after treatment.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Rabeprazole and Amoxicillin	Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 10 mg b.i.d.for 14 days.
DRUG	Amoxicillin and Rabeprazole	Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1 g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 20 mg b.i.d. for 14 days

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-10-01
• Completion: 2012-01-01
• First posted: 2012-01-20
• Last updated: 2012-01-20

Locations

1 site across 1 country: China