Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for First-line Treatment of Hp Infection

NCT ID: NCT02483715

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 589 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-05-31

Brief Summary

Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as 1st-line regimens for H. pylori eradication.

The aims of this study are:

1. to compare the efficacy of HDDT, and BQT as 1st-line 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

Participants, aged ≥ 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease teat, histology, and bacterial culture before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test. The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A, and B.

If the participants did not receive anti-H. pylori therapy previously, they will be invited to enter this study for evaluated the efficacy of these 1st-line regimens. Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens:

group A- HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);

group B- BQT ( rabeprazole 20 mg qid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days);

All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect 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, tablet, qid + amoxicillin 750 mg, capsule, qid for 14 days)

Group Type: EXPERIMENTAL

High-dose dual therapy (rabeprazole, amoxicillin)

Intervention Type: DRUG

High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)

Bismuth-containing quadruple therapy

group B-bismuth-containing quadruple therapy (rabeprazole 20 mg, tablet, bid + tripotassium dicitrate bismuthate 300 mg, tablet, qid + metronidazole 250 mg, tablet, qid + tetracycline 500 mg qid, capsule, for 10 days)

Group Type: ACTIVE_COMPARATOR

Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)

Intervention Type: DRUG

Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days)

Interventions

High-dose dual therapy (rabeprazole, amoxicillin)

High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)

Intervention Type: DRUG

Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)

Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days)

Intervention Type: DRUG

Other Intervention Names

Proton pump inhibitor, Rabeprazole, Pariet®; Antibiotics, Amoxicillin ,Amoxicillin®; Proton pump inhibitor, Rabeprazole, Pariet®; Antibiotics, Metronidazole, Flagyl®; Antibiotics, Tetracycline, Tetracycline®; Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®

Eligibility Criteria

Inclusion Criteria

Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy.

Exclusion Criteria

1. pregnant or nursing woman

2. serious concomitant illness and malignant tumor of any kind

3. history of hypersensitivity to test drugs

4. serious bleeding during the course of the ulcer

5. previous gastric surgery

6. receiving bismuth salts, PPIs, or antibiotics in the previous month.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

Countries

Taiwan

Other Identifiers

201503120MIND

Identifier Type: -

Identifier Source: org_study_id