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Comparison of the efficacy and safety between high-dose home-made Esomeprazole and brand-name Esomeprazole dual therapy for Helicobacter pylori eradication

Comparison of the efficacy and safety between high-dose home-made Esomeprazole and brand-name Esomeprazole dual therapy for Helicobacter pylori eradication:a prospective, open-label, randomized,parallel group, equivalence study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056653
Enrollment
Unknown
Registered
2022-02-09
Start date
2021-09-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Helicobacter pylori

Interventions

A group:home-made esomeprazole 20mg qid+amoxicillin 750mg qid for 14 days
B group:brand-name esomeprazole(Nexium) 20mg qid+amoxicillin 750mg qid for 14 days
Healthy controlled group:None

Sponsors

Department of Gastroenterology,Nanjing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
23 Years to 61 Years

Inclusion criteria

Inclusion criteria: 1.Ages between 18 and 65 years; Sexes eligible for study: both; 2.patients who are diagnosed with Helicobacter pylori; 3.treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months; 4.voluntary to be involved in the study and written informed consent was obtained from all patients.

Exclusion criteria

Exclusion criteria: 1. Allergy to the study drug (penicillin allergy, etc.); 2. Patients with chronic gastritis and peptic ulcer; 3. Patients who have received Helicobacter pylori eradication treatment within half a year; 4. Antibiotics, bismuth and probiotics were used 4 weeks before the start of the study, and histamine H2 receptor antagonists, PPI or potassium competitive acid blockers were used in the first 2 weeks; 5. Use of corticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants; 6. History of esophageal or gastric surgery; 7. Pregnant women and lactating women; 8. Suffer from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease and tumor; 9. Excessive drinking.

Design outcomes

Primary

MeasureTime frame
H.pylori eradication rate;

Secondary

MeasureTime frame
Adverse reaction assessment;Tongue coating microbiota;Gut microbiota;

Countries

China

Contacts

Public ContactZhenyu Zhang

Nanjing First Hospital

zzy6565@sina.com+86 718951670222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026