Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03383003
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2017-12-17
Brief Title:
Comparison of Two Novel First-line Anti-Helicobacter Pylori Therapy
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Comparison of Two Novel First-line Anti-Helicobacter Pylori Therapy A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2017-12
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:
The Asian-Pacific Consensus Report has recommended that proton pump inhibitor PPI-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection As a general rule for the treatment of other infectious diseases clinicians should prescribe therapeutic regimens that have a per-protocol eradication rate 90 for anti-H pylori therapy However the eradication rate of the standard triple therapy has generally declined to unacceptable levels ie 80 or less recently The reasons for this fall in efficacy with time may relate to the increasing incidence of clarithromycin-resistant strains of H pylori Clarithromycin resistance is the major cause of eradication failure for stand triple therapy Standard triple therapies should be abandoned in the areas with clarithromycin resistance 20 because the per-protocol eradication rates of standard therapies are often less than 85 and the intention-to-treat eradication rates are usually less than 807-10 day non-bismuth containing quadruple therapy Concomitant therapy had been successful in the presence of clarithromycin resistance Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained 90 eradication rate in some studies This novel treatment is simple and involved only two drugs and the most important of all is that amoxicillin resistance is still 0 in Taiwan High dose PPI has been used in several studies for H pylori eradication in order to increase the intra-gastric PH for optimal eradication So far there is still unclear which one is the best first-line H pylori eradication regimen with highest eradication rate and least adverse effects We therefore design a randomized controlled trial to simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the treatment outcomes of eradication therapies
Detailed Description:
The Asian-Pacific Consensus Report has recommended that proton pump inhibitor PPI-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection As a general rule for the treatment of other infectious diseases clinicians should prescribe therapeutic regimens that have a per-protocol eradication rate 90 for anti-H pylori therapy However the eradication rate of the standard triple therapy has generally declined to unacceptable levels ie 80 or less recently3-9 The reasons for this fall in efficacy with time may relate to the increasing incidence of clarithromycin-resistant strains of H pylori The main reasons for eradication failure for H pylori infection include antibiotic resistance poor compliance and rapid metabolism of PPI Clarithromycin resistance is the major cause of eradication failure for stand triple therapy The rate of clarithromycin-resistant strains ranged from 49 Spain to 1 Netherland worldwide Standard triple therapies should be abandoned in the areas with clarithromycin resistance 20 because the per-protocol eradication rates of standard therapies are often less than 85 and the intention-to-treat eradication rates are usually less than 80 7-10 day non-bismuth containing quadruple therapy Concomitant therapy had been successful in the presence of clarithromycin resistance Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained 90 eradication rate in some studies This novel treatment is simple and involved only two drugs and the most important of all is that amoxicillin resistance is still 0 in Taiwan High dose PPI has been used in several studies for H pylori eradication in order to increase the intra-gastric PH for optimal eradication So far there is still unclear which one is the best first-line H pylori eradication regimen with highest eradication rate and least adverse effects We therefore design a randomized controlled trial to simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the treatment outcomes of eradication therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None