High-dose Dual Therapy With Different Administration Frequencies

Randomized and Controlled Clinical Study of High-dose Dual Therapy With Different Administration Frequencies in the Treatment of Helicobacter Pylori

This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Amoxicillin; Drug: vonoprazan

Detailed Description

According to relevant literature research, amoxicillin TID groups (including before meal group and after meal group) were given Vonorasen (Takeda China) 20mg bid and Amoxicillin 1.0 TID (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.). Amoxicillin Qid group was given Vonorasen (Takeda China) 20mg bid and Amoxicillin 0.75 Qid (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.), all the drugs were purchased by the patients from the hospital. The three groups were treated for 14 days respectively, and 13C urea breath test was performed 6 weeks after drug withdrawal. The negative ones were judged as HP eradication.

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection

Exclusion Criteria:

• Pregnant and lactating women;
• History of gastrointestinal malignancies;
• History of previous subtotal gastrectomy;
• Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
• History of hematological diseases
• People who are allergic to drugs;
• The guardian or patient refused to join the group;
• Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
• No legal capacity or poor self-knowledge
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dual therapy A; Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc	Drug: Amoxicillin; Antibiotics for H. pylori eradication; Drug: vonoprazan; Potassium competitive acid blocker
Experimental: dual therapy B; Vonoprazan 20mg bid ac and amoxicillin 1g tid pc	Drug: Amoxicillin; Antibiotics for H. pylori eradication; Drug: vonoprazan; Potassium competitive acid blocker
Experimental: dual therapy C; Vonoprazan 20mg bid ac and amoxicillin 1g tid ac	Drug: Amoxicillin; Antibiotics for H. pylori eradication; Drug: vonoprazan; Potassium competitive acid blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradication rate	Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-rea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).	Six weeks after completion of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance rate	Compliance was defined as poor when they had taken less than 80% of the total medication	Within 7 days after completion of therapy
Rate of adverse events	The subjects were asked to record side effects and discomfort during treatment and actual drug administration.	Within 7 days after completion of therapy

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): September 10, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Dual Therapy
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: rjyy20210815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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