Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study

To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. pylori infection were compared in a multi-center clinical joint study in Jiangsu Province.

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection; Tegoprazan; Furazolidone
• Intervention / Treatment: Biological: Tegoprazan-amoxicillin dual therapy

Detailed Description

This study is a prospective, multicenter, open-label, randomized, parallel-controlled study. A total of 600 Hp-positive patients who had not received Hp eradication therapy before or who had previously eradicated Hp but had not undergone eradication therapy in the past six months were recruited, and the basic clinical data of the patients (age, gender, drug allergy history, diagnosis and treatment, etc.) were recorded, and they were randomly divided into two groups according to the ratio of 1:1. Group A subjects received oral Tegoprazan 50mg, bid + amoxicillin 1000mg, tid; Group B subjects received oral Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days.

During the 14-day eradication treatment period, all participants were asked to record their adverse reactions and adherence to the medication. On the 7th and 14th days of medication, the researchers will conduct follow-up visits through WeChat or telephone to determine the adverse reactions and compliance of the patients, and observe and record whether the subjects have nausea, diarrhea, dizziness, bitter mouth, rash, constipation and other adverse reactions. In addition, subjects returned to the hospital 4-6 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 18-65 years old;
2. Patients who have had a positive 13C or 14C breath test and have not received Helicobacter pylori eradication therapy before, or who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
3. Voluntarily join this trial and sign the informed consent form.

Exclusion Criteria:

1. Allergy to the study drug (penicillin, amoxicillin, furazolidone, Tegoprazan, etc.);
2. Patients with active peptic ulcer disease;
3. Patients who have received Helicobacter pylori eradication therapy within half a year;
4. Use of antibiotics, bismuth, histamine H2 receptor antagonists or PPIs for 4 weeks before starting study treatment;
5. use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. History of esophageal or gastric surgery;
7. Pregnant or lactating women;
8. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
9. Alcoholism.
10. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; oral Tegoprazan 50 mg, bid+amoxicillin 1000 mg, tid. The duration of treatment is 14 days.	Biological: Tegoprazan-amoxicillin dual therapy; A total of 600 Hp-positive patients who had not received Hp eradication therapy before or had had Hp eradication in the early stage but had not undergone eradication therapy in the past six months were randomly divided into two groups: group A subjects received Tegoprazan 50 mg, bid + amoxicillin 1000 mg, tid; Group B subjects received Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days. The eradication rate, adverse reactions, and compliance of the two groups were compared.; Other Names: Furazolidone-based Bismuth Quadruple Therapy
Active Comparator: Group B; oral Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days.	Biological: Tegoprazan-amoxicillin dual therapy; A total of 600 Hp-positive patients who had not received Hp eradication therapy before or had had Hp eradication in the early stage but had not undergone eradication therapy in the past six months were randomly divided into two groups: group A subjects received Tegoprazan 50 mg, bid + amoxicillin 1000 mg, tid; Group B subjects received Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days. The eradication rate, adverse reactions, and compliance of the two groups were compared.; Other Names: Furazolidone-based Bismuth Quadruple Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradication rate	The eradication effect of Helicobacter pylori was detected by 13C-UBT or 14C-UBT	4-6 weeks after the end of the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Security observations	Adverse reactions such as nausea, diarrhea, dizziness, change in taste, rash, constipation, etc	Days 7 and 14 of eradication treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance	Actual amount of medication taken as a proportion of the total amount of medication to be taken during the 14-day treatment period	Within 3 days after the end of treatment

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Monoamine Oxidase Inhibitors; Antacids; Anti-Infective Agents, Urinary; Antitrichomonal Agents; Amoxicillin; Bismuth; Furazolidone
• Other Study ID Numbers: KY20240123-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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