Clinical trial NCT05647278: A RCT of the Efficacy of Tegoprazan 50mg QD in the Treatment of Helicobacter Pylori Infection ( TATH-1 )
Official title: A RCT of the Efficacy of Tegoprazan 50mg QD Combined With Amoxicillin 750mg QID in the Treatment of Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vonoprazan
Helicobacter Pylori Infection
Proton Pump Inhibitor
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post- Treatment
timeFrame: Week 4 post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou first people's Hospital
state: Zhejiang
Study officials:
References: