NCT02487511

Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy

Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: St.Paul's Hospital, Korea · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7 or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended. This study aims to investigate which duration would be better for eradication of HP. The study design is a randomized controlled trial. The patients were randomly assigned to 7 days or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in both groups.

Detailed description

The recommended duration of triple therapy is typically 10 to 14 days in the United States and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole, bismuth-based quadruple therapy is commonly used as second-line therapy, however, the eradication rates was widely ranged according to the treatment duration. The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based quadruple therapy (2nd line therapy).

Conditions

• H.Pylori Gastrointestinal Disease

Interventions

Type	Name	Description
OTHER	Duration of HP therapy	the comparison of HP eradication rate between 7 days and 14 days

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-08-31
• Completion: 2017-01-31
• First posted: 2015-07-01
• Last updated: 2017-06-09

Locations

1 site across 1 country: South Korea