CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 240 enrolled
Drug / intervention
14-day sequential treatment +1 moredrug
Likely dose
14-day sequential treatment 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01085786
NCT01085786Phase 4Completed

Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection

Kaohsiung Veterans General Hospital.·interventional·Posted Mar 12, 2010·Updated Sep 21, 2015

In Brief

A Phase 4 clinical trial evaluating 14-day sequential treatment and 14-day hybrid treatment for Helicobacter Pylori Infection. Completed, enrolled 240 participants across 2 sites.

Detailed Summary

Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2010
Enrollment StartAug 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.3 years ago

Interventions

14-day sequential treatmentdrug

* 14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days * 14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days

14-day hybrid treatmentdrug

esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days