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

Shandong University

Status and phase: Not yet enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: 14-day high-dose Tegoprazan Dual Therapy (HDDT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05438550

2022SDU-QILU-G003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Helicobacter pylori infection (either positive for Helicobacter pylori culture, histopathological test, rapid urease test, C13/C14 urea breath test, or helicobacter pylori antigen test in feces).
• Patients who have not previously received helicobacter pylori eradication therapy.

Exclusion criteria

• Serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
• Those who are not willing to take contraceptive measures during pregnancy, lactation or the trial.
• Active gastrointestinal bleeding.
• History of drug allergy.
• Medication history of bismuth, antibiotics and PPI within 4 weeks.
• Other behaviors that may increase the risk, such as alcohol and drug abuse.
• Unable or unwilling to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 2 patient groups

14-day bismuth-containing quadruple therapy (BQT)

Active Comparator group

Description:

14-day bismuth-containing quadruple therapy (BQT) Nexium (Esomeprazole, Astrazeneca Pharmaceutical Co., LTD.) 20mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid

Treatment:

Drug: 14-day high-dose Tegoprazan Dual Therapy (HDDT)

14-day Tegoprazan high-dose dual therapy (HDDT)

Experimental group

Description:

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

Treatment:

Drug: 14-day high-dose Tegoprazan Dual Therapy (HDDT)