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

Phase 4

Completed

• Conditions: H.Pylori Gastrointestinal Disease
• Interventions: Other: Duration of HP therapy

• Registration Number: NCT02487511
• Lead Sponsor: St.Paul's Hospital, Korea

Brief 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).

Study Timeline

• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-01
• Study Start: 2015-08-01
• Primary Completion: 2016-08-31
• Study Completion: 2017-01-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

Inclusion Criteria

• Peptic ulcer including ulcer scar
• Early gastric cancer
• Gastric mucosa-associated lymphoid tissue lymphoma

Exclusion Criteria

• operation history
• liver cirrhosis
• chronic kidney disease
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
14 days	Duration of HP therapy	14 days treatment regimen

Primary Outcome Measures

Name	Time	Method
the comparison with 7days and 14days eradication rate of PPI based therapy	12 months after randomization

Secondary Outcome Measures

Name	Time	Method
the rate of side effects related to helicobacter eradication regimen	12 months after randomization

Trial Locations

Locations (1)

The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of