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High-dose Dual Therapy with Different Administration Frequencies

NCT ID: NCT05901051

Last Updated: 2024-12-30

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection

Keywords

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Helicobacter pylori Dual Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dual therapy A

Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc

Group Type EXPERIMENTAL

vonoprazan

Intervention Type DRUG

Potassium competitive acid blocker

Amoxicillin

Intervention Type DRUG

Antibiotics for H. pylori eradication

dual therapy B

Vonoprazan 20mg bid ac and amoxicillin 1g tid pc

Group Type EXPERIMENTAL

vonoprazan

Intervention Type DRUG

Potassium competitive acid blocker

Amoxicillin

Intervention Type DRUG

Antibiotics for H. pylori eradication

dual therapy C

Vonoprazan 20mg bid ac and amoxicillin 1g tid ac

Group Type EXPERIMENTAL

vonoprazan

Intervention Type DRUG

Potassium competitive acid blocker

Amoxicillin

Intervention Type DRUG

Antibiotics for H. pylori eradication

Interventions

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vonoprazan

Potassium competitive acid blocker

Intervention Type DRUG

Amoxicillin

Antibiotics for H. pylori eradication

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Qiu S, Huang Y, Chen J, Guo Y, Li M, Ding Z, Liang X, Lu H. Vonoprazan-Amoxicillin Dual Therapy With Different Amoxicillin Administration Regimens for Helicobacter pylori Treatment: A Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13118. doi: 10.1111/hel.13118.

Reference Type DERIVED
PMID: 39087868 (View on PubMed)

Other Identifiers

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rjyy20210815

Identifier Type: -

Identifier Source: org_study_id