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

NCT ID: NCT01513785

Last Updated: 2012-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group R20A

All the patients were sent to a penicillin skin test before treatment except they were given penicillin before. The group R20A will receive 14 days of Amoxicillin 1g t.i.d and Rabeprazole 20 mg b.i.d. PPI was taken 30 minutes before meals while antibiotic was taken 30 minutes after meals.

Group Type: ACTIVE_COMPARATOR

Amoxicillin and Rabeprazole

Intervention Type: DRUG

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

group R10A

All the patients were sent to a penicillin skin test before treatment except they were given penicillin before. The group R10A will receive 14 days of Amoxicillin 1g t.i.d and Rabeprazole 10 mg b.i.d. PPI was taken 30 minutes before meals while antibiotic was taken 30 minutes after meals.

Group Type: ACTIVE_COMPARATOR

Rabeprazole and Amoxicillin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Amoxycillin Capsules; Sodium Rabeprazole Enteric-coated Tablets; Amoxycillin Capsules; Sodium Rabeprazole Enteric-coated Tablets

Eligibility Criteria

Inclusion Criteria

Patients aged from 18 to 70 years, who presented with upper gastrointestinal symptoms and endoscopically proven H. pylori-positive non-ulcer dyspepsia, were recruited into the study.

Exclusion Criteria

• patients with peptic ulcer,
• previous H. pylori eradication treatment,
• previous gastric surgery,
• pregnancy,
• lactation,
• major systemic diseases,
• receipt of anti-secretory therapy,
• antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xiaobo Li

Xiaobo Li

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li X B, M.D., Ph.D.

Role: STUDY_CHAIR

Shanghai Jiao-Tong University School of Medicine Renji Hospital

Locations

GI Division, Shanghai Jiao-Tong University School of Medicine Renji Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

rjyyxhk0904

Identifier Type: -

Identifier Source: org_study_id