Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study.

Helicobacter Pylori Infection Clinical Trial

Official title:
Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study

Status Not yet recruiting

Clinical Trial Summary

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Clinical Trial Description

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06412588
Study type	Interventional
Source	Nanjing First Hospital, Nanjing Medical University
Contact	Zhenyu Zhang
Phone	18951670222
Email	zhangzhenyu808@126.com
Status	Not yet recruiting
Phase	N/A
Start date	May 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
Completed	`NCT02557932` - Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication	Phase 3
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
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	`NCT05549115` - Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection	N/A
Recruiting	`NCT05728424` - One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL	Phase 3
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.