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

Helicobacter Pylori Infection Clinical Trial

Official title:
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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Helicobacter Pylori Infection

Clinical Trial Details

NCT number	NCT06340334
Study type	Interventional
Source	Nanjing First Hospital, Nanjing Medical University
Contact
Status	Not yet recruiting
Phase	N/A
Start date	March 2024
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05061732` - Helicobacter Pylori Eradication and Follow-up	Phase 4
Completed	`NCT03779074` - Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies	Phase 3
Completed	`NCT06076681` - A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules	Phase 1/Phase 2
Recruiting	`NCT05329636` - Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy	Phase 1/Phase 2
Recruiting	`NCT05065138` - Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists	N/A
Completed	`NCT05049902` - Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication	Phase 4
Not yet recruiting	`NCT06200779` - Tailored vs. Empirical Helicobacter Pylori Infection Treatment	Phase 4
Not yet recruiting	`NCT06037122` - Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
Completed	`NCT04617613` - Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait	Phase 4
Withdrawn	`NCT02552641` - Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole	Phase 4
Completed	`NCT02873247` - Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
Completed	`NCT02557932` - Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication	Phase 3
Recruiting	`NCT02249546` - Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection	Phase 4
Completed	`NCT01933659` - Anti-H. Pylori Effect of Deep See Water	Phase 3
Unknown status	`NCT01464060` - 14-day Quadruple Hybrid vs. Concomitant Therapies for Helicobacter Pylori Eradication	Phase 4
Completed	`NCT00841490` - Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults	N/A
Recruiting	`NCT05728424` - One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL	Phase 3
Recruiting	`NCT05549115` - Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection	N/A
Recruiting	`NCT05997433` - Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)	N/A
Completed	`NCT04708405` - The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.