Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy (THC)

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Eradication Rates of the Two Regimens

Treatments: Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin); Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)

Study type: Interventional

Funder types: Other

Identifiers

NCT01607918

201110019MD

Details and patient eligibility

About

The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days

Enrollment: 1,300 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.
• Written informed consents will be obtained from all patients prior to enrollment.

Exclusion criteria

Patients will be excluded from the study if any one of the following criteria is present:

• children and teenagers aged less than 20 years,
• history of gastrectomy,
• gastric malignancy, including adenocarcinoma and lymphoma,
• previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
• pregnant or lactating women,
• severe concurrent disease
• Patients who cannot give informed consent by himself or herself.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 2 patient groups

Sequential therapy 10 days

Experimental group

Description:

Sequential therapy

Treatment:

Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)

Triple therapy 14 days

Active Comparator group

Description:

Triple therapy

Treatment:

Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin)