Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Ten-day Amoxicillin-containing Dual Therapy as First-line Helicobacter Pylori Treatment in Elderly Patients: a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419674
• Other study ID #: 2022-0323
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: June 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Qin Du, Master
• Phone: +86 0571-89713734
• Email: duq518[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 393
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹4C-urea breath test and/or biopsy;

2. underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment;

3. with no historical treatment for helicobacter pylori infection.

Exclusion Criteria:

1. administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion

2. with previous esophageal or gastric surgery

3. with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases

4. allergy to any of the study drugs

5. participated in other research within 3 months,cannot express his/her own ideas correctly or cannot cooperate with the researcher

Related Conditions & MeSH terms

• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Vonoprazan
Potassium-competitive acid blocker
• Rabeprazole
Proton pump inhibitor
• Amoxicillin
Antibiotic for H. pylori eradication
• Clarithromycin
Antibiotic for H. pylori eradication
• Colloidal bismuth pectin
Gastric mucosal protective drug with anti-H. pylori effect

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University, School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori Eradication Rate	Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.	Six to eight weeks after completion of the medication
Secondary	Rate of Adverse Drug Reaction(ADR)	Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure).	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