High-dose Dual Therapy With Different Administration Frequencies

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901051
• Other study ID #: rjyy20210815
• Status: Completed
• Phase: Phase 4
• Start date: March 30, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: September 30, 2023
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• vonoprazan
Potassium competitive acid blocker
• Amoxicillin
Antibiotics for H. pylori eradication

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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