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Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02776371
Enrollment
301
Registered
2016-05-18
Start date
2016-09-30
Completion date
2018-02-28
Last updated
2018-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Eradication Rate

Keywords

Helicobacter pylori, Sequential therapy, Modified non-clarithromycin triple therapy

Brief summary

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

Interventions

DRUGModified 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.

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.

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
the difference of eradication rates between 2 groups5 months

Secondary

MeasureTime frame
the different rates of adverse events between 2 groups5 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026