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

NCT06340334 | Completed

• 1 other identifier: KY20240123-05
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tegoprazan; Furazolidone; Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Security observations

  Days 7 and 14 of eradication treatment

Other Outcomes (1)

• Patient compliance

  Within 3 days after the end of treatment

Study Arms (2)

Group A

EXPERIMENTAL

oral Tegoprazan 50 mg, bid+amoxicillin 1000 mg, tid. The duration of treatment is 14 days.

Biological: Tegoprazan-amoxicillin dual therapy

Group B

ACTIVE COMPARATOR

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

Interventions

Tegoprazan-amoxicillin dual therapy BIOLOGICAL

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.

Also known as: Furazolidone-based Bismuth Quadruple Therapy

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old;
• 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;
• Voluntarily join this trial and sign the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: March 31, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 10, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)