CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 232 enrolled
Drug / intervention
10-day sequential treatment +1 moredrug
Likely dose
10-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/NCT00656968
NCT00656968Phase 4Completed

Sequential Versus Concomitant Therapy for Helicobacter Pylori Infection

Kaohsiung Veterans General Hospital.·interventional·Posted Apr 14, 2008·Updated Sep 30, 2015

In Brief

A Phase 4 clinical trial evaluating 10-day sequential treatment and 10-day concomitant therapy for Helicobacter Infection. Completed, enrolled 232 participants across 2 sites.

Detailed Summary

Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain forms of gastric cancer. Curing this infection generally requires that patients take 2 or more antibiotic medications and a stomach acid suppressing medication for about two weeks. Current treatments do not always cure the infection and a new treatment is being tested in this study. The drugs involved in the new 4 drug treatment have been widely used for treatment of this infection. It remains unknown what is the best and most cost effective way to give them. This study will compare three different ways of using these drugs. Subjects must have active Helicobacter pylori infection in order to participate in this study.

Study Details

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

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 14, 2008
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.2 years ago

Interventions

10-day sequential treatmentdrug

esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10

10-day concomitant therapydrug

esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10