Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

Helicobacter Pylori Eradication Rate Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776371
• Other study ID #: 2016SDU-QILU-05
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: February 2018

Study information

• Verified date: December 2018
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: February 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication Rate

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difference of eradication rates between 2 groups		5 months
Secondary	the different rates of adverse events between 2 groups		5 months