Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study.

Helicobacter Pylori Infection Clinical Trial

Official title:

Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412588
• Other study ID #: KY20240123-18
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Zhenyu Zhang
• Phone: 18951670222
• Email: zhangzhenyu808[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Description:

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 810
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65 years old;

2. Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;

3. Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;

4. Voluntarily join this trial and sign the informed consent form.

Exclusion Criteria:

1. Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);

2. Patients with confirmed active peptic ulcer;

3. Patients who have received Helicobacter pylori eradication therapy within half a year;

4. Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;

5. Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;

6. History of esophageal or gastric surgery;

7. Pregnant or lactating women;

8. Alcoholism

9. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;

10. Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;

11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days
Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days.
• Vonoprazan+Amoxicillin
Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days.
• Vonoprazan+doxycycline
Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Security observations	Adverse drug reactions	Within 3 days after the end of treatment
Primary	HP eradication rate	The eradication effect of Helicobacter pylori was tested by 13C-UBT or 14C-UBT	4-6 weeks after the end of the last dose
Secondary	Patient compliance	Rate of drug consumption during the treatment period of the subjects	Within 3 days after the end of treatment