Viewing Study NCT01085786



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Last Modification Date: 2024-10-26 @ 10:17 AM
Study NCT ID: NCT01085786
Status: COMPLETED
Last Update Posted: 2015-09-21
First Post: 2010-03-11

Brief Title: Sequential and Hybrid Therapies for H Pylori Infection
Sponsor: Kaohsiung Veterans General Hospital
Organization: Kaohsiung Veterans General Hospital

Study Overview

Official Title: Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection
Status: COMPLETED
Status Verified Date: 2015-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: The purpose of this study is to test whether the 14-day sequential therapy esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole clarithromycin and metronidazole for 7 days or 14-day hybird therapy esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole amoxicillin clarithromycin and metronidazole for 7 days can achieve an eradication rate equal to or more than 95

A total of 240 subjects will be asked to participate in this study

H pylori-infected patients are randomized to either a 14-day sequential therapy 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 or a hybrid therapy 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

Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H pylori therapy The eradication rates of the two study groups will be compared

A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None