Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

Phase 4

Completed

• Conditions: Helicobacter Pylori Eradication Rate
• Interventions: Drug: Modified non-clarithromycin triple therapy; Drug: Sequential therapy

• Registration Number: NCT02776371
• Lead Sponsor: Shandong University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-15
• Study First Submitted QC: 2016-05-15
• Study First Posted: 2016-05-18
• Study Start: 2016-09
• Primary Completion: 2018-01
• Study Completion: 2018-02
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified non-clarithromycin triple therapy	Modified non-clarithromycin triple therapy	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.
Sequential therapy	Sequential therapy	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.

Primary Outcome Measures

Name	Time	Method
the difference of eradication rates between 2 groups	5 months

Secondary Outcome Measures

Name	Time	Method
the different rates of adverse events between 2 groups	5 months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China