An Open-label, Single-center, Randomized Controlled Trial Investigating Different Regimens for Eradication of Helicobacter pylori Infection with the Inclusion of Tegoprazan

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400084473

Enrollment

Unknown

Registered

2024-05-17

Start date

2024-05-20

Completion date

Unknown

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

A: Tegola + amoxicillin:Tegola tablets 50mg, orally, twice daily (30 minutes before breakfast and dinner) + Amoxicillin capsules 1g, orally, three times daily (after breakfast, lunch, and dinner).Trea

B: Tegola tablets + Amoxicillin capsules + Potassium bismuth citrate capsules:Tegola tablets 50mg, orally, twice daily (30 minutes before breakfast and dinner) + Amoxicillin capsules 1g, orally, three

C Group: Esomeprazole tablets + Amoxicillin capsules + Potassium bismuth citrate capsules + Clarithromycin tablets:C Group: Esomeprazole tablets 20mg, orally, twice daily + Amoxicillin capsules 1g, or

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Positive result in the 13C-urea breath test (13C-UBT). 2) Patients undergoing their first eradication treatment. 3) Patients aged 18 to 70 years, of any gender. 4) Prior to medication, acid-suppressing drugs should be discontinued for at least 2 weeks, and antibiotics, bismuth preparations, and H2 receptor antagonists should be discontinued for at least 4 weeks. 5) Voluntary participation in this study and willingness to comply with ethical principles.

Exclusion criteria

Exclusion criteria: 1.Patients who have used acid-suppressing drugs within the past 2 weeks or antibiotics, bismuth preparations, and H2 receptor antagonists within the past 4 weeks. 2.Patients who have previously undergone H. pylori eradication. 3.Patients with known allergies to the components of the medication used in this study or with a history of allergies. 4.Patients with active peptic ulcer, gastric cancer, gastrointestinal bleeding, or a history of gastric surgery. 5.Patients with severe cardiovascular, cerebrovascular, respiratory, liver, or kidney diseases, as well as patients with mental disorders. 6.Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Eradication Rate of Helicobacter pylori Infection;	—

Secondary

Measure	Time frame
adverse event rate;	—

Countries

China

Contacts

Public ContactFucheng Zhang; Jiyong Wu

Shandong Second ProvinciaI GeneraI HospitaI

zhangfucheng6666@163.com+86 531 8308 6516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026