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

NCT06523764 | Active Not Recruiting Phase 4

• 1 other identifier: KY20242230-C-1
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection Chronic Gastrit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Safety)

  14 days of treatment

• Rate of participants with good medication compliance (Compliance)

  14 days of treatment

Study Arms (2)

tegoprazan and minocycline dual theropy

EXPERIMENTAL

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

Drug: tegoprazan; Drug: Minocycline

Bismuth-containing quadruple therapy

ACTIVE COMPARATOR

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; Drug: Esomeprazole 40mg; Drug: Amoxicillin; Drug: clarithromycin

Interventions

tegoprazan DRUG

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

Also known as: minocycline

tegoprazan and minocycline dual theropy

Minocycline DRUG

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

tegoprazan and minocycline dual theropy

bismuth potassium citrate DRUG

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 DRUG

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

Amoxicillin DRUG

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 DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18\~70,both gender.
• Patients with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
• Patients are willing to receive eradication treatment.
• Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after th

You may not qualify if:

• Patients with contraindications or allergies to the study drug.
• Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
• 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).
• Pregnant or lactating women.
• Underwent upper gastrointestinal Surgery.
• Patients with moderate to severe dysplasia or high degree of intraepithelial neopla
• Patients have symptom of dysphagia.
• Evidence of bleeding or iron efficiency anemia.
• A history of malignancy.
• Drug or alcohol abuse history in the past 1 year.
• Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
• Patients who has psychological problem or poor compliance.
• Enrolled in other clinical trials in the past 3 months.
• Refuse to sign informed conse

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Interventions

tegoprazan; Minocycline; Esomeprazole; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Yongquan Shi,

  Chinaa, Shaanxi Xijing Hosipital of Digestive Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: November 11, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)