Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02483715
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2015-06-11
Brief Title:
Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for First-line Treatment of Hp Infection
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Efficacy of High-dose Dual Therapy Versus Bismuth-containing Quadruple Therapy for First-line Treatment of Helicobacter Pylori Infection - A Prospective Randomized Comparative Study
Status:
COMPLETED
Status Verified Date:
2019-03
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:
Up to now there is few randomized large scale study prospectively and simultaneously comparing the efficacy adverse effects and patient adherence of high-dose dual therapy HDDT and bismuth-containing quadruple therapy BQT as 1st-line regimens for H pylori eradication
The aims of this study are
1 to compare the efficacy of HDDT and BQT as 1st-line regimen in H pylori eradication
2 to compare the patient adherence and adverse effects of these treatment regimens
3 to investigate factors that may influence H pylori eradication by these treatment regimens
The aims of this study are
1 to compare the efficacy of HDDT and BQT as 1st-line regimen in H pylori eradication
2 to compare the patient adherence and adverse effects of these treatment regimens
3 to investigate factors that may influence H pylori eradication by these treatment regimens
Detailed Description:
Participants aged 20 having H pylori-positive chronic gastritis withwithout peptic ulcers duodenal or gastric ulcers will be recruited All undergo endoscopy with biopsy for rapid urease teat histology and bacterial culture before treatment Four to eight weeks after termination of treatment H pylori infection status will be examined by the 13C-urea breath test The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase PCR-RFLP method A computed generated random numbers sequence will be blocked into two subgroups say A and B
If the participants did not receive anti-H pylori therapy previously they will be invited to enter this study for evaluated the efficacy of these 1st-line regimens Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens
group A- HDDT rabeprazole 20 mg qid amoxicillin 750 mg qid for 14 days
group B- BQT rabeprazole 20 mg qid tripotassium dicitrate bismuthate 300 mg qid metronidazole 250 mg qid tetracycline 500 mg qid for 10 days
All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period Post-treatment the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect of treatment
If the participants did not receive anti-H pylori therapy previously they will be invited to enter this study for evaluated the efficacy of these 1st-line regimens Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens
group A- HDDT rabeprazole 20 mg qid amoxicillin 750 mg qid for 14 days
group B- BQT rabeprazole 20 mg qid tripotassium dicitrate bismuthate 300 mg qid metronidazole 250 mg qid tetracycline 500 mg qid for 10 days
All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period Post-treatment the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect of treatment
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