Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

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

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Eradication Rate
• Intervention / Treatment: Drug: Modified non-clarithromycin triple therapy; Drug: Sequential therapy

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the difference of eradication rates between 2 groups	5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
the different rates of adverse events between 2 groups	5 months

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: May 15, 2016
• First Submitted That Met QC Criteria: May 15, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Sequential therapy; Modified non-clarithromycin triple therapy
• Other Study ID Numbers: 2016SDU-QILU-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No