Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06156085
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2023-11-12
Brief Title:
Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy
Sponsor:
Fu Jen Catholic University Hospital
Organization:
Fu Jen Catholic University Hospital
Study Overview
Official Title:
Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy A Randomized Controlled Trial in Taiwan
Status:
RECRUITING
Status Verified Date:
2023-11
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:
BackgroundHelicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer Its now a consensus of experts that Hpylori infection should be treated once it is recognized Extended proton pump inhibitor PPI-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 907 95 CI 874 - 940 Nevertheless its complexity of the sequential usage is sometimes confusing to the patients and may lead to treatment failure The emerging new regimen - vonoprazan-based dual therapy on the other hand is another appealing choice with simplicity and low pill burden However theres still no evidence regarding the use of vonoprazan-based dual therapy with high-dose amoxicillin 1000mg twice daily as the first-line regimen in Taiwan This study aimed to compare the efficacy of the current standard first-line regimen sequential therapy with that of vonoprazan-based dual therapy with high-dose Amoxicillin
Objectives To compare the efficacy of the current standard first-line regimen sequential therapy with that of vonoprazan-based dual therapy through a randomized controlled trial
Methods Patients with Hpylori infection who was over 20 years old and agree to participate in the trial will be recruited Those who had received Hpylori eradication before are known to be allergic to any drug used in this trial are pregnant or refuse to participate in the trial for any reason will be excluded We then allocate these patients into two groups randomly - one group receiving vonoprazan-based dual therapy with high-dose amoxicillin vonoprazan 20 mg amoxicillin 1000 mg twice daily for fourteen days and the other receiving extended sequential therapy lansoprazole 30mg plus amoxicillin 1000mg twice daily for 7 days followed by lansoprazole 30mg clarithromycin 500mg and metronidzole 500mg twice daily for an additional 7 days Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment
Outcome analysis The study will be designed as a non-inferiority trial We anticipate that the two regimens will have comparable efficacy Besides well also design a questionnaire to evaluate the adverse effects whether they took the drugs in the right way and patients satisfaction of the drug regimen The vonoprazan dual therapy with high-dose amoxicillin will be anticipated to have fewer adverse effects better compliance and better satisfaction
Objectives To compare the efficacy of the current standard first-line regimen sequential therapy with that of vonoprazan-based dual therapy through a randomized controlled trial
Methods Patients with Hpylori infection who was over 20 years old and agree to participate in the trial will be recruited Those who had received Hpylori eradication before are known to be allergic to any drug used in this trial are pregnant or refuse to participate in the trial for any reason will be excluded We then allocate these patients into two groups randomly - one group receiving vonoprazan-based dual therapy with high-dose amoxicillin vonoprazan 20 mg amoxicillin 1000 mg twice daily for fourteen days and the other receiving extended sequential therapy lansoprazole 30mg plus amoxicillin 1000mg twice daily for 7 days followed by lansoprazole 30mg clarithromycin 500mg and metronidzole 500mg twice daily for an additional 7 days Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment
Outcome analysis The study will be designed as a non-inferiority trial We anticipate that the two regimens will have comparable efficacy Besides well also design a questionnaire to evaluate the adverse effects whether they took the drugs in the right way and patients satisfaction of the drug regimen The vonoprazan dual therapy with high-dose amoxicillin will be anticipated to have fewer adverse effects better compliance and better satisfaction
Detailed Description:
BackgroundHelicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer Its now a consensus of experts that Hpylori infection should be treated once it is recognized Extended proton pump inhibitor PPI-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 907 95 CI 874 - 940 Nevertheless its complexity of the sequential usage is sometimes confusing to the patients and may lead to treatment failure The emerging new regimen - vonoprazan-based dual therapy on the other hand is another appealing choice with simplicity and low pill burden However theres still no evidence regarding the use of vonoprazan-based dual therapy with high-dose amoxicillin 1000mg twice daily as the first-line regimen in Taiwan This study aimed to compare the efficacy of the current standard first-line regimen sequential therapy with that of vonoprazan-based dual therapy with high-dose Amoxicillin
Objectives To compare the efficacy of the current standard first-line regimen sequential therapy with that of vonoprazan-based dual therapy through a randomized controlled trial
Methods Patients with Hpylori infection who was over 20 years old and agree to participate in the trial will be recruited Those who had received Hpylori eradication before are known to be allergic to any drug used in this trial are pregnant or refuse to participate in the trial for any reason will be excluded We then allocate these patients into two groups randomly - one group receiving vonoprazan-based dual therapy with high-dose amoxicillin vonoprazan 20 mg amoxicillin 1000 mg twice daily for fourteen days and the other receiving extended sequential therapy lansoprazole 30mg plus amoxicillin 1000mg twice daily for 7 days followed by lansoprazole 30mg clarithromycin 500mg and metronidzole 500mg twice daily for an additional 7 days Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment
Outcome analysis The study will be designed as a non-inferiority trial We anticipate that the two regimens will have comparable efficacy Besides well also design a questionnaire to evaluate the adverse effects whether they took the drugs in the right way and patients satisfaction of the drug regimen The vonoprazan dual therapy with high-dose amoxicillin will be anticipated to have fewer adverse effects better compliance and better satisfaction
Objectives To compare the efficacy of the current standard first-line regimen sequential therapy with that of vonoprazan-based dual therapy through a randomized controlled trial
Methods Patients with Hpylori infection who was over 20 years old and agree to participate in the trial will be recruited Those who had received Hpylori eradication before are known to be allergic to any drug used in this trial are pregnant or refuse to participate in the trial for any reason will be excluded We then allocate these patients into two groups randomly - one group receiving vonoprazan-based dual therapy with high-dose amoxicillin vonoprazan 20 mg amoxicillin 1000 mg twice daily for fourteen days and the other receiving extended sequential therapy lansoprazole 30mg plus amoxicillin 1000mg twice daily for 7 days followed by lansoprazole 30mg clarithromycin 500mg and metronidzole 500mg twice daily for an additional 7 days Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment
Outcome analysis The study will be designed as a non-inferiority trial We anticipate that the two regimens will have comparable efficacy Besides well also design a questionnaire to evaluate the adverse effects whether they took the drugs in the right way and patients satisfaction of the drug regimen The vonoprazan dual therapy with high-dose amoxicillin will be anticipated to have fewer adverse effects better compliance and better satisfaction
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?:
False
Is an FDA AA801 Violation?:
None