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

NCT01513785 | Completed Phase 2

• 1 other identifier: rjyyxhk0904
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Keywords

H. pylori; Dual therapy; Amoxicillin; Rabeprazole

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• antibiotic resistance

  3 weeks

Study Arms (2)

group R20A

ACTIVE COMPARATOR

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.

Drug: Amoxicillin and Rabeprazole

group R10A

ACTIVE COMPARATOR

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.

Drug: Rabeprazole and Amoxicillin

Interventions

Rabeprazole and Amoxicillin 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.

Also known as: Amoxycillin Capsules, Sodium Rabeprazole Enteric-coated Tablets

group R10A

Amoxicillin and Rabeprazole 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

Also known as: Amoxycillin Capsules, Sodium Rabeprazole Enteric-coated Tablets

group R20A

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Interventions

Rabeprazole; Amoxicillin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Li X B, M.D., Ph.D.

  Shanghai Jiao-Tong University School of Medicine Renji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xiaobo Li

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

CN (1)