MedDataX Logo

Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication

NCT ID: NCT06168214

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-04

Study Completion Date

2024-12-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:

* Main indicators: the eradication rate of Helicobacter pylori for eradication.
* Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vonoprazan Hp Dual or Triple Eradication Regimes

NCT05345210

Helicobacter Pylori
UNKNOWN PHASE4

Vonoprazan in Helicobacter Pylori Treatment an RCT

NCT04901663

Helicobacter Pylori Infection
COMPLETED PHASE4

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy

NCT02296021

Gastritis Peptic Ulcer Dyspepsia
COMPLETED PHASE4

Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

NCT05014334

Helicobacter Pylori Infection Chronic Gastritis
COMPLETED PHASE4

Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

NCT04907747

Helicobacter Pylori Infection
UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

the Eradication Rates of Helicobacter Pylori

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days

14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.

Group Type ACTIVE_COMPARATOR

Rabeprazloe+bismuth+amoxicillin+clarithromycin

Intervention Type DRUG

PBAC: 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.

Vonoprazan+amoxicillin+clarithromycin 14 days

14D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.

Group Type EXPERIMENTAL

Vonoprazan+amoxicillin+clarithromycin 14 days

Intervention Type DRUG

VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.

Vonoprazan+amoxicillin+clarithromycin 7 days

7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.

Group Type EXPERIMENTAL

Vonoprazan+amoxicillin+clarithromycin 7 days

Intervention Type DRUG

VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.

Vonoprazan+tetracycline+furazolidone 14 days

14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.

Group Type EXPERIMENTAL

Vonoprazan+tetracycline+furazolidone 14 days

Intervention Type DRUG

VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.

Vonoprazan+tetracycline+furazolidone 7 days

7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.

Group Type EXPERIMENTAL

Vonoprazan+tetracycline+furazolidone 7 days

Intervention Type DRUG

VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.

Vonoprazan+amoxicillin+furazolidone 7 days

7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; F: furazolidone 100mg bid.

Group Type EXPERIMENTAL

Vonoprazan+amoxicillin+furazolidone 7 days

Intervention Type DRUG

hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.

Vonoprazan+amoxicillin+tetracycline 14 days

7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; T: tetracycline 500mg tid.

Group Type EXPERIMENTAL

Vonoprazan+amoxicillin+tetracycline 14 days

Intervention Type DRUG

hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.

Vonoprazan+amoxicillin 7 days

7D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid.

Group Type EXPERIMENTAL

Vonoprazan+amoxicillin 7 days

Intervention Type DRUG

hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.

Vonoprazan+amoxicillin 14 days

14D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid.

Group Type EXPERIMENTAL

Vonoprazan+amoxicillin 14 days

Intervention Type DRUG

hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rabeprazloe+bismuth+amoxicillin+clarithromycin

PBAC: 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.

Intervention Type DRUG

Vonoprazan+amoxicillin+clarithromycin 14 days

VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.

Intervention Type DRUG

Vonoprazan+amoxicillin+clarithromycin 7 days

VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.

Intervention Type DRUG

Vonoprazan+tetracycline+furazolidone 14 days

VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.

Intervention Type DRUG

Vonoprazan+tetracycline+furazolidone 7 days

VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.

Intervention Type DRUG

Vonoprazan+amoxicillin+furazolidone 7 days

hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.

Intervention Type DRUG

Vonoprazan+amoxicillin+tetracycline 14 days

hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.

Intervention Type DRUG

Vonoprazan+amoxicillin 7 days

hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.

Intervention Type DRUG

Vonoprazan+amoxicillin 14 days

hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.

Exclusion Criteria

* Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Han Ying

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ying han

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ying Han

Role: primary

[email protected]
+86-29-84771539

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJLL-KY-20230499

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection
NCT05590286 UNKNOWN PHASE4
A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis
NCT03908619 UNKNOWN PHASE4
The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
NCT04728516 RECRUITING PHASE4
Efficacy of Vonoprazan in Eradication of Resistant Strain of Helicobacter Pylori
NCT06414707 COMPLETED PHASE3
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection
NCT04167670 COMPLETED PHASE3
Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection
NCT07275827 NOT_YET_RECRUITING PHASE3
VA Dual Sequential Therapy
NCT06929962 RECRUITING PHASE4
The Role of CYP2C19 on the Eradication of H. Pylori Infection:Implication of PK/PD Relationships
NCT00162877 UNKNOWN NA
Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection
NCT07040839 NOT_YET_RECRUITING PHASE4
The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets
NCT06337604 COMPLETED PHASE1
Vonoprazan for Helicobacter Pylori Eradication in Adolescents
NCT06162949 COMPLETED PHASE3
Comparison of Rabeprazole and Esomperazole for the Eradication of H. Pylori
NCT02767479 COMPLETED PHASE3
Tegoprazan- Versus PPI-based H. Pylori Eradication
NCT06682533 RECRUITING
AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers
NCT00325715 COMPLETED PHASE1
High Dose PPI Triple Therapy Versus Sequential Therapy for Helicobacter Pylori Eradication
NCT01888237 COMPLETED PHASE4
Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients
NCT05933031 UNKNOWN PHASE2
Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control
NCT00713947 WITHDRAWN PHASE4
Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.
NCT00216450 COMPLETED PHASE4
A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole
NCT04494243 COMPLETED PHASE1
Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection
NCT07165444 RECRUITING NA
A Randomized Multi-Intervention Trial to Inhibit Precancerous Gastric Lesions in Lingu, Shandong Province
NCT00339768 COMPLETED PHASE3
A Study To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Subjects With Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Induced Gastropathy
NCT02788123 TERMINATED PHASE4
Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication
NCT06101420 COMPLETED PHASE3
A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole
NCT04622358 COMPLETED PHASE1
A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755
NCT07141381 RECRUITING PHASE1