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A prospective, randomized, open, multicenter clinical study on the efficacy of tegoprazan plus amoxicillin in the treatment of patients with Helicobacter pylori

A prospective, randomized, open, multicenter clinical study on the efficacy of tegoprazan plus amoxicillin in the treatment of patients with Helicobacter pylori - A clinical study on the efficacy of tegoprazan plus amoxicillin in the treatment of patients with Helicobacter pylori

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071997
Enrollment
Unknown
Registered
2023-05-31
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Helicobacter pylori infection

Interventions

A:Amoxicillin (1000mg each time, three times a day) + tegoprazan (50mg each time, once a day) for 2 weeks
B:Amoxicillin (1000mg each time, three times a day) + tegoprazan(50mg each time, twice a day) for 2 weeks
C:Amoxicillin (1000mg twice daily)+ clarithromycin (500mg twice daily)+ bismuth (220mg twice daily)+ esomeprazole (20mg twice daily) for 2 weeks

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Adult patients, aged 18 to 70 years; 2.Patients who did not take antibiotics, bismuth and traditional Chinese medicine 4 weeks before treatment, and patients who took PPI, H2 receptor antagonists and other drugs 2 weeks before treatment; 3.Hp-positive was diagnosed by C13 or C14-urea breath test and rapid urease test; 4.Informed and agreed to participate in the study, patients with complete medical records and follow-up records.

Exclusion criteria

Exclusion criteria: 1.With severe heart, lung, and kidney dysfunction and low immunity; 2.Patients with drug allergy contraindications; 3.Persons with mental illness or communication difficulties; 4.Pregnancy, lactation; 5.Patients with organic diseases such as gastrointestinal tumor and gastrointestinal hemorrhage.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
dverse reaction;antibiotic resistance of Helicobacter pylori;flora;Degree of clinical symptom remission;

Countries

China

Contacts

Public ContactZhihui Lin

Fujian Provincial Hospital

13799371368@139.com+86 137 9937 1368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026