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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiaobo Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01513785
First received: January 16, 2012
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Functional Dyspepsia
Drug: Rabeprazole and Amoxicillin
Drug: Amoxicillin and Rabeprazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New Dual Therapy for Primary Treatment of Helicobacter Pylori Infection:a Pilot Study

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 13C-urea breath test [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: Yes ]
    When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).


Secondary Outcome Measures:
  • antibiotic resistance [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 40
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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
Other Names:
  • Amoxycillin Capsules
  • Sodium Rabeprazole Enteric-coated Tablets
Active Comparator: 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.
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.
Other Names:
  • Amoxycillin Capsules
  • Sodium Rabeprazole Enteric-coated Tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513785

Locations
China, Shanghai
GI Division, Shanghai Jiao-Tong University School of Medicine Renji Hospital
Shanghai, Shanghai, China, 200001
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Chair: Li X B, M.D., Ph.D. Shanghai Jiao-Tong University School of Medicine Renji Hospital
  More Information

No publications provided

Responsible Party: Xiaobo Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01513785     History of Changes
Other Study ID Numbers: rjyyxhk0904
Study First Received: January 16, 2012
Last Updated: January 19, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
H. pylori
Dual therapy
Amoxicillin
Rabeprazole

Additional relevant MeSH terms:
Dyspepsia
Helicobacter Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014