Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy

NCT ID: NCT01265069

Last Updated: 2013-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-12-31

Brief Summary

Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy.

The aims of this study are:

1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue regimen in H. pylori eradication;

2. to compare the patient adherence and adverse effects of these treatment regimens;

3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Detailed Description

Patients, aged 18, having H. pylori-positive chronic gastritis with/without peptic ulcers will be recruited. All undergo endoscopy with biopsy before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by endoscopy with biopsy or the Carbon 13-urea breath test if the patients refuse the second endoscopy. The cytochrome P450 (CYP)2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A and B.

If the patients had received anti-H. pylori therapy previously, they will be invited to enter the study for evaluating the efficacy of rescue regimens. After giving their written informed consent, all patients will be labeled with numbers by enrolling order. Each patient will be randomly allocated to one of two treatment groups which receives medications for 10 to 14 days:

group A - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B - concomitant therapy (rabeprazole 20 mg + amoxicillin 1000 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for 10 days).

All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily in a diary card during the treatment period. Post-treatment, the patients will be seen at the Outpatient Clinic to investigate patient adherence and adverse effects of treatment.

Conditions

Helicobacter Pylori Infection

Study Design

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

Study Groups

high dose dual therapy

Group A - high dose dual therapy (rabeprazole 20 mg qid, amoxicillin 750 mg qid for 14 days)

Group Type: ACTIVE_COMPARATOR

high dose dual therapy

Intervention Type: DRUG

rabeprazole 20mg qid,amoxicillin 750mg qid for 14days

concomitant therapy

Group B - concomitant therapy (rabeprazole 20 mg, amoxicillin 1000 mg, metronidazole 500 mg, clarithromycin 500 mg, bid for 10 days).

Group Type: EXPERIMENTAL

concomitant therapy

Intervention Type: DRUG

rabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days

Interventions

high dose dual therapy

rabeprazole 20mg qid,amoxicillin 750mg qid for 14days

Intervention Type: DRUG

concomitant therapy

rabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years and are willing to received eradication therapy.

Exclusion Criteria

• pregnant or nursing woman
• serious concomitant illness and malignant tumor of any kind
• history of hypersensitivity to test drugs
• serious bleeding during the course of this ulcer
• previous gastric surgery
• receiving bismuth salts, proton pump inhibitors, or antibiotics in the previous month.

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

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jyh-Chin Yang, M.D.Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jyh-Chin Yang, M.D.Ph.D

Role: CONTACT

jcyang47@ntu.edu.tw

886-2-23123456 ext. 65055

Facility Contacts

Jyh-Chin Yang, M.D.Ph.D.

Role: primary

jcyang47@ntu.edu.tw

886-2-23123456 ext. 65055

Other Identifiers

201005064M

Identifier Type: -

Identifier Source: org_study_id