Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial

Phase 4

Completed

• Conditions: Helicobacter Infected Patients
• Interventions: Drug: sequential versus triple

• Registration Number: NCT01418300
• Lead Sponsor: Jun-Won Chung

Brief Summary

The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study First Submitted: 2011-08-13
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Study Completion: 2011-12
• Last Update Submitted: 2015-04-26
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• peptic ulcer diseae
• two test positive rapid urease test, culture, histology

Exclusion Criteria

• lactating or pregnant
• previous stomach surgery
• severe underlying disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sequential therapy	sequential versus triple	first five day amoxicillin+PPI later five day PPI+clarithromycin+metronidazole
conventional triple thearpy	sequential versus triple	PPI+amoxicillin+clarithromycin

Primary Outcome Measures

Name	Time	Method
the eradication rate by urea breath test	4-6 week later after completion of therapy	to compare the eradication rate (intention-to-treat and per protocol) by urea breath test at least four weeks after treatment

Trial Locations

Locations (1)

Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of