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

Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment : A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Helicobacter Pylori Infection Chronic Gastrit
• Intervention / Treatment: Drug: tegoprazan; Drug: Minocycline; Drug: bismuth potassium citrate; Drug: Esomeprazole 40mg; Drug: Amoxicillin; Drug: clarithromycin

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tegoprazan and minocycline dual theropy; tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days	Drug: tegoprazan; tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days; Other Names: minocycline; Drug: Minocycline; tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
Active Comparator: Bismuth-containing quadruple therapy; bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days	Drug: bismuth potassium citrate; bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days; Drug: Esomeprazole 40mg; bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days; Drug: Amoxicillin; bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days; Drug: clarithromycin; bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradication rate	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	28 days after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Investigators: Principal Investigator: Yongquan Shi,, Chinaa, Shaanxi Xijing Hosipital of Digestive Disease

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Expectorants; Respiratory System Agents; Antacids; Protein Synthesis Inhibitors; Diuretics; Natriuretic Agents; Cytochrome P-450 CYP3A Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Minocycline; Potassium Citrate; Bismuth; Amoxicillin; Clarithromycin; Esomeprazole
• Other Study ID Numbers: KY20242230-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No