Helicobacter Pylori Infection Chronic Gastrit
Conditions
Brief summary
The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Interventions
DRUGtegoprazan
tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
DRUGMinocycline
tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
DRUGbismuth potassium citrate
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
DRUGEsomeprazole 40mg
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
DRUGAmoxicillin
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
DRUGclarithromycin
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18\ 70,both gender. 2. Patients with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment; 3. Patients are willing to receive eradication treatment. 4. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after th
Exclusion criteria
1. Patients with contraindications or allergies to the study drug. 2. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases. 3. Constant use of anti-ulcer drugs ( including taking proton- pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening). 4. Pregnant or lactating women. 5. Underwent upper gastrointestinal Surgery. 6. Patients with moderate to severe dysplasia or high degree of intraepithelial neopla 7. Patients have symptom of dysphagia. 8. Evidence of bleeding or iron efficiency anemia. 9. A history of malignancy. 10. Drug or alcohol abuse history in the past 1 year. 11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 12. Patients who has psychological problem or poor compliance. 13. Enrolled in other clinical trials in the past 3 months. 14. Refuse to sign informed conse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication rate | 28 days after treatment | The primary end point of this study is H.pylori eradication,established by negative urea breath test#rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treament |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety) | 14 days of treatment | Newly occurring drug-related symptoms during the treatment process |
| Rate of participants with good medication compliance (Compliance) | 14 days of treatment | Taking more than 80% of medication is defined as good compliance |
Countries
China
Outcome results
None listed