Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment

Xijing Hospital of Digestive Diseases

Status and phase: Active, not recruiting; Phase 4

Conditions: Helicobacter Pylori Infection Chronic Gastrit

Treatments: Drug: clarithromycin; Drug: Minocycline; Drug: Amoxicillin; Drug: bismuth potassium citrate; Drug: tegoprazan; Drug: Esomeprazole 40mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06523764

KY20242230-C-1

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

tegoprazan and minocycline dual theropy

Experimental group

Description:

tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days

Treatment:

Drug: tegoprazan

Drug: Minocycline

Bismuth-containing quadruple therapy

Active Comparator group

Description:

bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days

Treatment:

Drug: Esomeprazole 40mg

Drug: bismuth potassium citrate

Drug: Amoxicillin

Drug: clarithromycin