NCT05438550

14-day Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection

14-day High-dose Tegoprazan Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection: a Prospective, Randomized, Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomized to 14 days of dual therapy with Tegoprazan or 14 days of quadruple therapy with bismuth for eradication. At 6 weeks after treatment, subjects underwent another 13C-urea breath test. The eradication rate, adverse reaction rate and patient compliance were calculated.

Detailed description

1. Informed consent: Patients with positive Helicobacter pylori were collected in the outpatient department, and the subjects receiving initial treatment signed informed consent. 2. Safety evaluation: C13 urea breath test, blood routine test, urine routine test, electrolyte test and liver and kidney function test were performed to confirm helicobacter pylori infection. 3. Confirm the inclusion of patients: fill in the case report form and enter group A or group B according to the randomization results. Group A: 14-day Tegoprazan high-dose dual therapy (HDDT) Tegoprazan 50mg bid Amoxicillin 750mg qid Group B: 14-day bismuth-containing quadruple therapy (BQT) Esomeprazole 20mg bid Amoxicillin 1000mg bid Tetracycline 500mg qid Potassium bismuth citrate 2g bid 4. Supervised medication: follow up the medication situation and adverse reactions by telephone 14 days after taking medication, and remind the reexamination 6 weeks after stopping medication. 5. Results: C13 urea breath test was repeated 6 weeks after drug withdrawal. Blood routine, urine routine, electrolytes and liver and kidney function tests were performed. 6. Complete the Case Report Form: Fill in the case report form accurately. 7. Data analysis: SPSS software was used for statistical analysis.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	14-day high-dose Tegoprazan Dual Therapy (HDDT)	14-day Tegoprazan high-dose dual therapy (HDDT) Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid To investigate the efficacy of high-dose dual therapy of Tegoprazan, a novel p-CAB acid suppressant, combined with amoxicillin for the eradication of Helicobacter pylori

Timeline

• Start date: 2023-02-14
• Primary completion: 2023-12-20
• Completion: 2023-12-31
• First posted: 2022-06-30
• Last updated: 2023-02-14

Locations

1 site across 1 country: China