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

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513785
• Other study ID #: rjyyxhk0904
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2012
• Last updated: January 19, 2012
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Functional Dyspepsia
• Helicobacter Infections

Intervention

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.
• 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

Locations

Country	Name	City	State
China	GI Division, Shanghai Jiao-Tong University School of Medicine Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	13C-urea breath test	When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).	4 weeks after treatment	Yes
Secondary	antibiotic resistance	H. pylori strains were isolated and antibiotic resistance was measured by the twofold agar dilution method.Minimal inhibitory concentrations (MIC) of Metronidazole (Met), Clarithromycin (Cla), and Amoxicillin (Amo) were determined.MIC of Met>8ug/ml, Cla>2ug/ml, Amo>8ug/ml were determined as resistance breakpoints	3 weeks	No