CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 307 enrolled
Drug / intervention
7-day quadruple therapy +2 moredrug
Likely dose
7-day quadruple therapy 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/NCT01769365
NCT01769365Phase 4Completed

Comparison of 7-day Triple, 10-day Sequential, and 7-day Concomitant Therapies for Helicobacter Pylori Infection in Taiwan

Kaohsiung Veterans General Hospital.·interventional·Posted Jan 16, 2013·Updated Nov 17, 2017

In Brief

A Phase 4 clinical trial evaluating 7-day quadruple therapy, 10-day sequential therapy, and 1 other intervention for Helicobacter Pylori Infection. Completed, enrolled 307 participants across 1 site.

Detailed Summary

To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2013
Enrollment StartJul 1, 2010
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.5 years ago

Interventions

7-day quadruple therapydrug

pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days

10-day sequential therapydrug

pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days

7-day standard triple therapydrug

pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days