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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05438550
• Other study ID #: 2022SDU-QILU-G003
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 14, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Shandong University
• Contact: Xiuli Zuo, MD, PhD
• Phone: 86 15588818685
• Email: zuoxiuli[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 258
• Est. completion date: December 31, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

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

Locations

Country	Name	City	State
China	Qilu hosipital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate	Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.	immediately after the procedure
Secondary	Rate of adverse reactions	Rate of adverse reactions	Immediately after the procedure
Secondary	Patient compliance	Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.	Immediately after the procedure