Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

Shandong University

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Eradication Rate

Treatments: Drug: Modified non-clarithromycin triple therapy; Drug: Sequential therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02776371

2016SDU-QILU-05

Details and patient eligibility

About

Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.

Enrollment: 301 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent.

Exclusion criteria

• negative in rapid urease test (RUT)
• previous standard eradication therapy for H. pylori;
• history of esophagectomy or gastrectomy;
• gastrointestinal malignancy;
• contraindications or allergic to study drugs;
• user of taking medicine that may affect the result of the study within 4 weeks (e.g., proton-pump inhibitors, H2-receptor antagonists, bismuth or antibiotics etc.);
• cardiopulmonary, hepatic or renal insufficiency, and/or severe current diseases or malignancy;
• pregnant or lactating women;
• participants of other trial within the past 3 months;
• unwilling or unable to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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301 participants in 2 patient groups

Modified non-clarithromycin triple therapy

Experimental group

Description:

H.pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.

Treatment:

Drug: Modified non-clarithromycin triple therapy

Sequential therapy

Active Comparator group

Description:

H.pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.

Treatment:

Drug: Sequential therapy