A RCT of the Efficacy of Tegoprazan 50mg QD in the Treatment of Helicobacter Pylori Infection ( TATH-1 )

• Status: Active, not recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of Tegoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, some studies use Tegoprazan instead of common proton pump inhibitor, but almost all use double dose of Tegoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 50mg QD of Tegoprazan. Therefore, in this study, 50mg QD of Tegoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of Tegoprazan on Helicobacter pylori.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zhang Xiaofeng,MD
• Treatments: Esomeprazole

Criteria

Inclusion Criteria:

1. Patients aged ≥18 years with Hp-positive first sterilization were included in this study.

2. Before treatment, the existence of Helicobacter pylori can be confirmed by one or more of the following methods: rapid urease test, Hp culture, 13C urea breath test, 14C urea breath test and stool Hp antigen test.

Exclusion Criteria:

1. acute upper gastrointestinal bleeding.

2. active gastric or duodenal ulcer.

3. acute gastric or duodenal mucosal lesions.

4. previous eradication treatment of Helicobacter pylori.

5. penicillin/furazolidone allergy.

6. surgery that may affect gastric acid secretion (upper gastrointestinal resection or vagotomy).

7. Zollinger-Ellison syndrome or other hypergastric acid secretion diseases.

8. severe neurological, cardiovascular, pulmonary, liver,renal, metabolic,gastrointestinal, urological, etc.

9. Any fertile woman must use proper contraception.