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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: 14-day high-dose Tegoprazan Dual Therapy (HDDT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 258
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiuli Zuo, MD,PhD; Phone Number: 0531-88369277 86 15588818685; Email: zuoxiuli@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 14-day bismuth-containing quadruple therapy (BQT); 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	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; Other Names: Tegoprazan (Rosin Pharmaceutical Group Co. LTD.) 50mg bid; Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid
EXPERIMENTAL: 14-day Tegoprazan high-dose 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	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; Other Names: Tegoprazan (Rosin Pharmaceutical Group Co. LTD.) 50mg bid; Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of adverse reactions	Rate of adverse reactions	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 14, 2023
• Primary Completion (ANTICIPATED): December 20, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (ACTUAL): June 30, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Helicobacter Pylori Infection; High dose dual therapy; Bismuth-containing quadruple therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: 2022SDU-QILU-G003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No