Clincosm LogoSign in Get a demo

High-dose Dual Therapy With Different Administration Frequencies

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05901051
Collaborator
(none)
1
Enrollment
1
Location
3
Arms
29.9
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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, 274 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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

According to relevant literature research, amoxicillin TID group was 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 two 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 Design

Study Type:
Interventional
Anticipated Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized and Controlled Clinical Study of High-dose Dual Therapy With Different Administration Frequencies in the Treatment of Helicobacter Pylori
Actual Study Start Date :
Mar 30, 2021
Anticipated Primary Completion Date :
Sep 16, 2023
Anticipated Study Completion Date :
Sep 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: dual therapy A

Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc

Drug: vonoprazan
Proton pump inhibitor

Drug: Amoxicillin
Antibiotics for H. pylori eradication
Experimental: dual therapy B

Vonoprazan 20mg bid ac and amoxicillin 1g tid pc

Drug: vonoprazan
Proton pump inhibitor

Drug: Amoxicillin
Antibiotics for H. pylori eradication
Experimental: dual therapy C

Vonoprazan 20mg bid ac and amoxicillin 1g tid ac

Drug: vonoprazan
Proton pump inhibitor

Drug: Amoxicillin
Antibiotics for H. pylori eradication

Outcome Measures

Primary Outcome Measures

  1. Helicobacter pylori eradication rate [Six weeks after completion of therapy]

    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).

Secondary Outcome Measures

  1. Rate of adverse effects [Within 7 days after completion of therapy]

    The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).

  2. Compliance rate [Within 7 days after completion of therapy]

    Compliance was defined as poor when they had taken less than 80% of the total medication

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Ability and willingness to participate in the study and to sign and give informed consent

  • Confirmed H. pylori infection without previous treatment experience

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai China 200127

Sponsors and Collaborators

  • Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT05901051
Other Study ID Numbers:
  • rjyy20210815
First Posted:
Jun 13, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine
Helicobacter pylori
Dual Therapy
Additional relevant MeSH terms:
Amoxicillin

Study Results

No Results Posted as of Jun 13, 2023