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

Phase 4

Not yet recruiting

• Conditions: Helicobacter Pylori Infection Chronic Gastrit
• Interventions: Drug: bismuth potassium citrate; Drug: tegoprazan; Drug: Esomeprazole 40mg; Drug: Minocycline; Drug: Amoxicillin; Drug: clarithromycin

• Registration Number: NCT06523764
• Lead Sponsor: Xijing Hospital of Digestive Diseases

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Study Start: 2024-09
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bismuth-containing quadruple therapy	bismuth potassium citrate	bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
Bismuth-containing quadruple therapy	Esomeprazole 40mg	bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
tegoprazan and minocycline dual theropy	tegoprazan	tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
tegoprazan and minocycline dual theropy	Minocycline	tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
Bismuth-containing quadruple therapy	Amoxicillin	bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
Bismuth-containing quadruple therapy	clarithromycin	bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of participants with good medication compliance (Compliance)	14 days of treatment	Taking more than 80% of medication is defined as good compliance
Incidence of Treatment-Emergent Adverse Events (Safety)	14 days of treatment	Newly occurring drug-related symptoms during the treatment process