High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy of High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori Rescue Treatment: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024527
• Other study ID #: rjyy20190715
• Status: Completed
• Phase: Phase 4
• Start date: July 25, 2019
• Est. completion date: May 24, 2021

Study information

• Verified date: September 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: May 24, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants with non-ulcer functional dyspepsia or peptic ulcer disease

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

• Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria:

• Less than 18 years old or older than 80 years

• With previous gastric surgery

• Major systemic diseases

• Pregnancy or lactation

• Allergy to any of the study drugs

• Administration of antibiotics, bismuth,antisecretory drugs in 8 weeks prior to inclusion

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Esomeprazole
Proton pump inhibitor
• Amoxicillin
Antibiotic for H. pylori eradication
• Metronidazole
Antibiotic 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-urea 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 effects	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)	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