Ignite Creation Date:
2024-05-06 @ 12:41 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03829150
Status:
COMPLETED
Last Update Posted:
2019-05-14
First Post:
2019-01-28
Brief Title:
Dexlansoprazole MR-Based Concomitant Quadruple Therapy
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
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 ie 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 ie 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 ie 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 qdclarithromycin 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 ie 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 qdclarithromycin 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:
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