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

Phase 4

Active, not recruiting

• Conditions: Vonoprazan; Proton Pump Inhibitor; Helicobacter Pylori Infection
• Interventions: Drug: Tegoprazan; Drug: Esomeprazole

• Registration Number: NCT05647278
• Lead Sponsor: Zhang Xiaofeng,MD

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-11-23
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-02
• Last Update Submitted: 2022-12-02
• Study First Posted: 2022-12-12
• Last Update Posted: 2022-12-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tegoprazan 50mg QD	Tegoprazan	Tegoprazan 50mg, tablets, orally, qd given in combination with amoxicillin 750mg capsules, orally, qid for up to 2 weeks
Esomeprazole 20 mg BID	Esomeprazole	esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks. OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post- Treatment	Week 4 post-treatment	HP infection status will be determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.

Trial Locations

Locations (1)

Hangzhou first people's Hospital; 🇨🇳 Hangzhou, Zhejiang, China