Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Helicobacter Pylori Infection Chronic Gastrit
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 minocycli...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06523764
Start Date
November 11 2024
End Date
October 1 2025
Last Update
July 3 2025
Active Locations (1)
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1
Xijing hospital
Xi'an, Shaanxi, China, 710032