Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT03829150
Status:
COMPLETED
Last Update Posted:
2019-05-14
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexlansoprazole MR-Based Concomitant Quadruple Therapy
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
Anti-Helicobacter Pylori Therapy With Dexlansoprazole MR-Based Concomitant Quadruple Therapy- A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2019-05
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:
Background:
Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of \>90 % in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication
Aim:
The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy
Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of \>90 % in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication
Aim:
The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy
Detailed Description:
Background:
Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of \>90% in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication
Aim:
The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy
Methods:
Two hundred and two consecutive H. pylori-infected participants are randomly assigned to a 7-day Dexlansoprazole MR-based non-bismuth quadruple therapy (Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days) or a 7-day lansoprazole-based non-bismuth quadruple therapy (Lansoprazole 30 mg bid. , clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days). Participants are asked to return at the 2nd week to assess drug compliance and adverse events. Repeated endoscopy with rapid urease test, histological examination is performed at the 8th week after the end of anti- H. pylori therapy. If participants refuse follow-up endoscopy, urea breath tests are conducted to assess H. pylori status. The rates of eradication are analyzed by intention-to-treat and per-protocol analysis.
Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of \>90% in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication
Aim:
The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy
Methods:
Two hundred and two consecutive H. pylori-infected participants are randomly assigned to a 7-day Dexlansoprazole MR-based non-bismuth quadruple therapy (Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days) or a 7-day lansoprazole-based non-bismuth quadruple therapy (Lansoprazole 30 mg bid. , clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days). Participants are asked to return at the 2nd week to assess drug compliance and adverse events. Repeated endoscopy with rapid urease test, histological examination is performed at the 8th week after the end of anti- H. pylori therapy. If participants refuse follow-up endoscopy, urea breath tests are conducted to assess H. pylori status. The rates of eradication are analyzed by intention-to-treat and per-protocol analysis.
Study Oversight
Has Oversight DMC:
True
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?: